Intubation devices and methods of use

ABSTRACT

Intubation devices and methods of intubating a patient are provided. The intubation devices include a laryngeal mask airway (LMA) component having a mask portion and a tube portion and an endotracheal tube (ETT) component positioned in the laryngeal mask airway (LMA) component having a translatable and/or rotatable endotracheal tube. The endotracheal tube can be translated and/or rotated by a manipulation rod extending through the laryngeal mask airway (LMA) component and mounted to the endotracheal tube (ETT). The intubation devices may include inflatable cuffs adapted to manipulate the positioning or orientation of the endotracheal tube and/or to seal openings about the endotracheal tubes. Various ports, passages, and conduits are provided to enhance the use and manipulation of the intubation device.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority from pending U.S. Provisional PatentApplication 62/674,255, filed on May 21, 2018, and from pending U.S.Provisional Patent Application 62/769,467, filed on Nov. 19, 2018, thedisclosures of which are included by reference herein in their entirety.

BACKGROUND OF THE INVENTION Technical Field

This invention is generally related to intubation devices and the use ofintubation devices, for example, in operating rooms, emergency rooms,and by first responders. Specifically, aspects of the invention includedevices having a laryngeal mask airway (LMA) component and anendotracheal tube (ETT) component that translates and/or rotates withinthe laryngeal mask airway (LMA) component, the translation and/orrotation of which is externally controlled.

Description of Related Art

Laryngeal mask airways (LMAs) are conventional supra-glottic (that is,above the glottic or laryngeal opening) devices used, for example,during surgery, to maintain access to the trachea of the patient.Endotracheal tubes (ETTs) are also conventional tubes specially designedwith inflatable cuffs to seal the trachea and effectively supportoxygenation and ventilation, for example, during surgery.

Combination LMAs and ETTs, refereed to as “intubating laryngeal maskairways” (ILMAs) are also known in the art. ILMAs are devices thatinclude an LMA component and an ETT component where the LMA is used as aconduit for passing the ETT into the trachea of the patient. Thispassage of the ETT through the LMA is typically cumbersome anddifficult, and thus is often referred to as “railroading” the ETTthrough the LMA. In the conventional art, once the ETT of the ILMA ispositioned within the patient, the LMA is removed—very carefully toprevent dislodging the ETT—and the ETT is then left in place to intubatethe patient, for example, during surgery.

However, it is well recognized in the art that the manipulation and useof ILMAs, including the “railroading” of the ETT, the connecting anddisconnecting of the appropriate hoses and fixtures, and the delicateremoval of the LMA while not dislodging the ETT, can be difficult andtime consuming. Of course, these prior art devices and practices arebeing performed on patients, where misstep or error can be harmful, ifnot life threatening.

Aspects of the invention address these and other disadvantages of theprior art by providing a unique combination of LMA and ETT that not onlyavoids the inconvenience and complications of the prior art, but alsocan provide unique opportunities for improved techniques and improvedpatient treatment and outcome.

SUMMARY OF THE INVENTION

According to one embodiment of the invention, a intubation device isprovided comprising or including a laryngeal mask airway (LMA) componentcomprising a mask portion having an internal opening, and an elongatedtube mounted to the mask portion, the elongated tube having an internalpassageway in fluid communication with the internal opening of the maskportion; a movable endotracheal tube (ETT) component comprising anelongated tube positioned and movable within the elongated tube of thelaryngeal mask airway component; and a manipulation rod operativelymounted to the ETT component, the manipulation rod adapted to allow anoperator to move the ETT component within the LMA component. Themanipulation rod may be adapted to allow the operator to translateand/or rotate the ETT component within the LMA component.

In one aspect, the device further comprises at least one inflatable cuffmounted to the elongated tube of the ETT component and at least one cuffinflation device operatively connected to the at least one inflatablecuff, wherein when at least partially inflated, the at least oneinflatable cuff at least partially restricts fluid flow about theelongated tube of the ETT component.

In another aspect, the mask portion of the laryngeal mask airway (LMA)component may include a plurality of projections adapted to contactmating tissue, for example, a plurality of surface corrugations.

In another aspect, the intubation device may further include a sealingdevice adapted to minimize fluid leakage about the manipulation rod, forexample, an elastomeric sealing device.

In another aspect, the intubation device may include a mask portion ofthe laryngeal mask airway (LMA) component having a distal end with anorogastric orifice. The laryngeal mask airway (LMA) may include a distalextension and the orogastric orifice may be located in the distalextension, and a conduit may be connected to the orogastric orifice.

In another aspect, the mask portion of the laryngeal mask airway (LMA)may include a structure adapted to receive and orient the passage of theelongated tube of the endotracheal tube (ETT) component, for example, anincline or a ramp.

According to another embodiment, an intubation device is provided. Theintubation device comprises or includes a laryngeal mask airway (LMA)component comprising a mask portion having an internal opening and anelongated tube mounted to the mask portion, the elongated tube having aninternal passageway in fluid communication with the internal opening ofthe mask portion; an endotracheal tube (ETT) component comprising anelongated tube positioned and moveable, for example, translatable and/orrotatable, within the elongated tube of the laryngeal mask airwaycomponent; and an extraction stop preventing extraction of theendotracheal tube from the internal passageway of the laryngeal maskairway component. In one aspect of this embodiment, the extraction stopmay be an obstruction within the internal passageway of the laryngealmask airway component.

In another aspect, the device may further include means for translatingthe endotracheal tube component within the internal passageway of thelaryngeal mask airway component. For example, in one aspect, theextraction stop may be an obstruction associated with the means fortranslating the endotracheal tube component. In another aspect, themeans for translating the endotracheal tube may be an elongated rodmounted to the endotracheal tube component, for example, mounted by aprojection or “tab” to the elongated tube to the endotracheal tubecomponent.

In another aspect, the device may further include a penetration stoppreventing penetration of the endotracheal tube beyond a predeterminedpenetration along the internal passageway of the laryngeal mask airwaycomponent. For example, in one aspect, the penetration stop may be anobstruction within the internal passageway of the laryngeal mask airwaycomponent. In another aspect, the laryngeal mask airway component mayinclude a slot adapted to guide translation of the endotracheal tube.

In another aspect of this embodiment of the invention, the intubationdevice may further include a conduit having a first opening at thedistal end of the laryngeal mask airway component and a second openingat the proximal end of the laryngeal mask airway component. For example,this conduit may be a gastric fluid extraction conduit. In one aspect,for this and any other embodiment disclosed herein, the first opening atthe distal end of the laryngeal mask airway component may be anorogastric orifice, as known in the art.

In another aspect, the device the device may include an endotrachealtube having one or more inflatable cuffs, for example, an inflatablecuff positioned at the distal end of the endotracheal tube.

In another aspect, the mask portion of the laryngeal mask airwaycomponent of the device, for this and any other embodiment disclosedherein, may have an extension having an opening at a distal end of theextension and an internal lumen in fluid communication with the opening,for example, an orogastric orifice. In one aspect, the extension may bea tapering extension.

In a further aspect, the mask portion of the laryngeal mask airwaycomponent of the intubation device may have a surface have projectionsor corrugations, for example, projections or corrugations adapted toenhance blood flow in the mating tissue.

In a still further aspect, the device may further include an inflatableballoon adapted to position the tube of the endotracheal tube component.In one aspect, the inflatable balloon may include a recess adapted toengage the tube during positioning of the tube.

Another embodiment of the invention is a method of intubating a patient,the method comprising or including: inserting an intubation devicecomprising or including: a laryngeal mask airway (LMA) componentcomprising a mask portion having an internal opening, and an elongatedtube mounted to the mask portion, the elongated tube having an internalpassageway in fluid communication with the internal opening of the maskportion; an endotracheal tube (ETT) component comprising an elongatedtube positioned and movable (for example, translatable and/or rotatable)within the elongated tube of the laryngeal mask airway component; and anextraction stop preventing extraction of the endotracheal tube from theinternal passageway of the laryngeal mask airway component; andtranslating the endotracheal tube (ETT) component within the laryngealmask airway (LMA) component to insert an end of the elongated tube ofthe endotracheal tube (ETT) component into a trachea of a patient;translating the endotracheal tube (ETT) component to extract the end ofthe elongated tube of the endotracheal tube (ETT) component out of thetrachea of the patient; and contacting the endotracheal tube (ETT)component against the extraction stop to prevent extraction of theendotracheal tube from the internal passageway of the laryngeal maskairway component.

In one aspect of this method, the intubation device may further compriseor include an elongated rod mounted to the endotracheal tube component;and wherein moving, for example, translating, the endotracheal tube maybe practiced by moving, for example, translating, the elongated rod.

In another aspect of this method, the elongated tube of the endotrachealtube (ETT) component may comprise or include one or more inflatablecuffs; and wherein the method may further comprise inflating the one ormore inflatable cuffs, for example, in the trachea of the patient.

In another aspect of this method, the mask portion of laryngeal maskairway (LMA) component may further comprise or include an inflatableballoon adapted to contact the elongated tube of the endotracheal tube(ETT) component; and wherein the method may further comprise or includeinflating the inflatable balloon to deflect the elongated tube of theendotracheal tube (ETT) component.

In another aspect of this method, the mask portion of laryngeal maskairway (LMA) component may be an inflatable mask portion having at leasta portion that can be inflated with a gas, such as, air, and deflated.

According to another embodiment, an intubation device is provided. Theintubation device comprises or includes a laryngeal mask airway (LMA)component comprising a mask portion having an internal opening and anelongated tube mounted to the mask portion, the elongated tube having aninternal passageway in fluid communication with the internal opening ofthe mask portion; an endotracheal tube (ETT) component comprising anelongated tube positioned within the elongated tube of the LMAcomponent; and a manipulation rod operatively mounted to the ETTcomponent, the manipulation rod adapted to allow an operator to move theETT component within the LMA component. In one aspect, the manipulationrod is adapted to allow an operator to translate and/or rotate the ETTcomponent within the LMA component.

In one aspect, the LMA component may further comprise a slot throughwhich the manipulation rod passes, wherein movement of the manipulationrod within the slot rotates the ETT component within the LMA component.

In one aspect, the device may further comprise a projection connectingthe manipulation rod to the ETT component.

In another aspect, the device may further comprise an elongated hole inthe LMA component through which the manipulation devices passes. Inanother aspect, a sealing device may be provided in the elongated holein the LMA component.

In another aspect, the LMA component may further comprise a conduitoperatively connected to the ETT component, and wherein the devicefurther comprises a sealing device between the conduit of the LMAcomponent and the ETT component.

In another aspect, the device may further comprise a hollow sleeve forreceiving the manipulation rod, for example, a flexible hollow sleeve.

In another aspect, the device may further comprise one or moreinflatable cuffs mounted to the ETT component and a cuff inflationballoon operatively connected to the inflatable cuff. In another aspect,the device may further comprise an inflatable cuff mounted about theinternal opening of the mask portion of the LMA and a cuff inflationballoon operatively connected to the inflatable cuff about the internalopening of the mask portion.

Another embodiment of the invention is a method of intubating a patient,the method comprising or including: inserting an intubation devicecomprising: a laryngeal mask airway (LMA) component comprising a maskportion having an internal opening and an elongated tube mounted to themask portion, the elongated tube having an internal passageway in fluidcommunication with the internal opening of the mask portion; anendotracheal tube (ETT) component comprising an elongated tubepositioned and movable (for example, translatable and/or rotatable)within the elongated tube of the LMA component; and a manipulation rodoperatively mounted to the ETT component; and, with the manipulationrod, moving the ETT component within the LMA component to facilitateinserting the ETT component into a trachea of the patient. In one aspectof the invention, moving the ETT component may be practiced bytranslating the ETT component and/or rotating the ETT component.

In another aspect, the LMA component may further comprise a slot throughwhich the manipulation rod passes, and wherein the method may furthercomprise moving the manipulation rod within the slot to rotate the ETTcomponent within the LMA component.

In another aspect, the LMA component may further comprise an elongatedhole through which the manipulation rod passes, and wherein the methodmay further comprise sealing the elongated hole to minimize fluidleakage. In another aspect, the LMA component may further comprise aconduit operatively connected to the ETT component, and wherein themethod may further comprise sealing an interface between the conduit ofthe LMA component and the ETT component.

In one aspect, the intubation device may further comprise one or moreinflatable cuffs mounted to the ETT component and one or more cuffinflation balloons operatively connected to the one or more inflatablecuff, and wherein the method may further comprise inflating the one ormore inflatable cuffs on the ETT component with the one or more cuffinflation balloons.

In another aspect, the intubation device may further comprise aninflatable cuff mounted about the internal opening of the mask portionand a cuff inflation balloon operatively connected to the inflatableinternal opening cuff, and wherein the method may further compriseinflating the inflatable cuff about the internal opening with the cuffinflation balloon.

These and other aspects, features, and advantages of the aspects of thisinvention will become apparent from the following detailed descriptionof the various aspects of the invention taken in conjunction with theaccompanying drawings

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter, which is regarded as the invention, is particularlypointed out and distinctly claimed in the claims at the conclusion ofthe specification. The foregoing and other objects, features, andadvantages of the invention will be readily understood from thefollowing detailed description of aspects of the invention taken inconjunction with the accompanying drawings in which:

FIG. 1 is a side, cross-sectional view of the anatomy of head/neck of apatient shown by dashed line illustrating a typical positioning of theintubation device according to one aspect of the invention and itsanatomical relationships as inserted in a patient.

FIG. 2 is a right side elevation view of the intubation device shown inFIG. 1.

FIG. 3 is a top view of the intubation device shown in FIG. 2.

FIG. 4 is a bottom view of the intubation device shown in FIG. 2.

FIG. 5 is a top view of the intubation device shown in FIG. 2, partiallyshown in cross section to illustrate details of the intubation device.

FIG. 6 is a detail view of the intubation device shown in FIG. 5, asidentified by Detail 6 shown in FIG. 5.

FIG. 6A is a detail view similar to FIG. 6 illustrating another aspectof the invention.

FIG. 6B is a partial plan view of an alternate mounting of amanipulation rod to an endotracheal tube according to one aspect of theinvention.

FIG. 6C is an end view, partially in cross section of the alternatemounting shown in FIG. 6B.

FIG. 7 is a bottom view of another intubation device having an internalpassage according to one aspect of the invention.

FIG. 8 is a top view of another intubation device having a tubeinflation cuff according to one aspect of the invention.

FIG. 9 is a front-end view of an intubation device according to oneaspect of the invention.

FIG. 10 is a rear end view of the intubation shown in FIG. 7 having afeed or extraction lumen, passage, or conduit according to one aspect ofthe invention.

FIG. 11 is a partial right side elevation view of an intubation devicehaving an extension having an extended feed or extraction lumen,passage, or conduit.

FIG. 12 is a partial bottom view of the intubation device shown in FIG.11.

FIG. 13 is a partial top plan view of an intubation device having a maskportion with surface corrugations or projections according to anotheraspect of the invention.

FIG. 13A is a partial side elevation view of the intubation device shownin FIG. 13 as viewed along view direction 13A shown in FIG. 13.

FIG. 14 is a partial right side elevation view of the intubation deviceshown in FIG. 13.

FIG. 15 is a front end perspective view of an intubation device having asealing device for the tube-translating rod or bar according to anotheraspect of the invention.

FIG. 15A is an elevation view of a front end of the intubation deviceshown in FIG. 15 having translation indicia on the tube-translating rodor bar according to another aspect of the invention.

FIG. 16 is a partial right side elevation view of an intubation devicehaving a tube deflecting balloon or cuff according to another aspect ofthe invention, the cuff shown uninflated.

FIG. 16A is a partial right side elevation view, partially in crosssection, of an intubation device having a tube guide incline accordingto another aspect of the invention.

FIG. 17 is a partial right side elevation view of intubation devicesimilar to FIG. 16 with the cuff shown inflated.

FIG. 18 is a partial bottom view of the intubation device shown in FIG.17 as viewed along view line 18 in FIG. 17.

FIG. 19 is a top view of an intubation device an intubation devicehaving an ETT component having multiple lumens according to anotheraspect of the invention.

FIG. 20 is a detail view of a top of an intubation device, similar tothe intubation device shown in FIG. 19, having multiple lumens for, forexample, bronchial isolation according to another aspect of theinvention.

FIG. 21 is a top view of an intubation device partially shown in crosssection to illustrate details of the intubation device having an ETTcomponent with a conduit according to another aspect of the invention.

FIG. 22 is a detail view of the intubation device shown in FIG. 21, asidentified by Detail 22 shown in FIG. 21.

FIGS. 23 and 24 are schematic illustrations of cross-section views of anLMA component tube portion and an ETT component tube illustratingrestriction to removing the ETT component tube according to one aspectof the invention.

FIG. 25 is a partial perspective view, partially in cross section, of anintubation device having a rotatable endotracheal tube (ETT) componentmounted for rotation within a laryngeal mask airway (LMA) componentaccording to one aspect of the invention.

FIG. 26 is a partial perspective view, partially in cross section,similar to FIG. 25, where the rotatable ETT component is rotated fromthe position shown in FIG. 25, for example, a first position, to theposition shown in FIG. 26, for example, one or more second positions,according to one aspect of the invention.

FIG. 27 is a partial perspective view, partially in cross section, of anintubation device having a translatable ETT component according to oneaspect of the invention.

FIG. 28 is a partial perspective view, partially in cross section, of aportion of the intubation device shown in FIG. 27 illustrating a sealingdevice according to one aspect of the invention.

FIG. 29 is a partial perspective view, partially in cross section, ofanother intubation device having translatable and/or rotatable ETTcomponent with a sealing device according to one aspect of theinvention.

FIG. 30 is a cross-sectional view of the engagement of the translatableand/or rotatable ETT component with an LMA conduit having a sealingdevice as identified by Detail 30 in FIG. 29 according to one aspect ofthe invention.

FIG. 31 is a detailed cross-sectional view of the engagement of atranslatable and/or rotatable ETT component with an LMA conduit havingsealing device as identified by Detail 31 in FIG. 30.

FIG. 32 is a front elevation view, partially in cross section, ofanother intubation device having a translatable and/or rotatable ETTcomponent having an indicator balloon according to one aspect of theinvention.

FIG. 33 is a detailed cross-sectional view of a portion of theintubation device shown in FIG. 32 as identified by Detail 33 in FIG.32.

FIG. 34 is a front elevation view, partially in cross section, ofanother intubation device having a translatable and/or rotatable ETTcomponent having one or more inflatable cuffs, one or more manipulationbars or rods, and one or more cuff inflation balloons according to oneaspect of the invention.

FIG. 35 is a detailed cross-sectional view of a portion of theintubation device shown in FIG. 34 as identified by Detail 35 in FIG.34.

FIG. 36 is another detailed cross-sectional view, similar to FIG. 35, ofa portion of the intubation device shown in FIG. 34 as identified byDetail 35 in FIG. 34 according to another aspect of the invention.

FIG. 37 is a perspective view of an end portion of the intubation deviceshown in FIG. 34 showing the engagement of the manipulation rod and thecuff inflation balloon with the intubation device according to oneaspect of the invention.

FIG. 38 is a detailed cross-sectional view of a portion of themanipulation rod sleeve having a sealing device shown in FIG. 37 asidentified by Detail 38 in FIG. 12.

FIG. 39 is a partial perspective view, partially in cross section, ofanother intubation device having a translatable and/or rotatable ETTcomponent and having a manipulation rod according to one aspect of theinvention.

FIG. 40 is a side elevation view of the partial perspective view of theintubation device shown in FIG. 39 as viewed along view lines 40-40shown in FIG. 39.

FIG. 41 is a front view of an intubation device having animage-capturing device and an image-capturing device access passageaccording to an aspect of the invention.

FIG. 42 is a front view of an intubation device having an inflatable ETTballoon cuff and a cuff inflation balloon according to an aspect of theinvention.

FIG. 43 is a front view of an intubation device having body cavities andsurface protrusions according to an aspect of the invention.

FIG. 44 is a partial side elevation view of the intubation device shownin FIG. 43.

FIG. 45 is a partial rear elevation view of the intubation device shownin FIGS. 43 and 44.

FIG. 46 is a front view of an intubation device having a multipartendotracheal tube (ETT) component, a balloon cuff, and balloon cuffinflation balloon according to an aspect of the invention.

FIG. 47 is a detailed cross-sectional view of the intubation deviceshown in FIG. 46, as identified by Detail 47 in FIG. 46, according toone aspect of the invention.

FIG. 48 is a front view of an intubation device having a multipartendotracheal tube (ETT) component, a balloon cuff, and balloon cuffinflation balloon according to another aspect of the invention.

FIG. 49 is a detailed cross-sectional view of the intubation deviceshown in FIG. 48 showing the engagement of portions of the multipart ETTcomponent via an interlocking mechanism as identified by Detail 49 shownin FIG. 48.

FIG. 50 is a perspective view of an intubation device having atranslatable ETT component (not shown) within a LMA component accordingto an aspect of the invention.

FIG. 51 is a perspective view of the intubation device shown in FIG. 50with the LMA component shown in phantom to facilitate illustration ofthe translatable ETT component.

FIG. 52 is a side view of the intubation device shown in FIG. 51 withthe LMA component shown in phantom to facilitate illustration of thetranslatable ETT component.

FIG. 53 is a top view of the intubation device shown in FIG. 52 with theLMA component shown in phantom to facilitate illustration of thetranslatable ETT component.

FIG. 54 is a perspective view of portions of the connector and relatedcomponents of the intubation device shown in FIGS. 50 through 53 toillustrate the relationship of the components.

FIG. 55 is a perspective view of portions of the ETT component, aninflation balloon conduit, and manipulation rod sleeve, with theconnector remove, to illustrate the relationship of these components.

FIG. 56 is a perspective view of portions of the ETT component, theinflation balloon conduit, and the manipulation rod sleeve, withconnector removed, similar to FIG. 55, but with the sleeve and the ETTcomponent shown in phantom to illustrate aspects of the invention.

FIG. 57 is a front perspective view of the connector shown in FIG. 54,according to one aspect of the invention.

FIG. 58 is a rear perspective view of the connector shown in FIG. 57.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a side view of a cross-section of the anatomy of the head/neckof a patient P illustrating a typical positioning of an intubationdevice to according to one aspect of the invention and the anatomicalrelationships of device to as inserted in patient P. As shown in FIG. 1,device to includes a laryngeal mask airway (LMA) component, or LMA, 12and an endotracheal tube (ETT) component, or ETT, 14 shown in dashedline in FIG. 1. As is typical of the art, the laryngeal mask air way(LMA) component 12 is adapted to be inserted into the patient P and“mask” the larynx 16 (or path to the trachea 18) of the patient P toisolate the trachea 18. The isolation of the trachea (or “windpipe”) 18then permits the ETT component 14 to pass into the trachea 18, and, forexample, avoid the esophagus 20. The LMA component 12 may typicallyinclude a tube portion 22 and a mask portion 24 having an opening, orinternal opening, 25, through which the ETT component 14 passes.

According to aspects of the invention, the ETT component 14 of device tois mounted for translation and/or rotation within the LMA component 12of device to, and may be prevented, for example, substantially preventedduring use, from being removed or extracted from the LMA component 12.As disclosed herein, though many different means may be provided fortranslating and substantially preventing extraction or removal of ETTcomponent 14, in one aspect, device to includes at least one extractionstop, generally indicated by arrow 26 in FIG. 1, which substantiallyprevents extraction or removal of the endotracheal tube component 14from the internal passageway of the laryngeal mask airway component 12.

As also shown in FIG. 1, the translation of ETT component 14 within LMAcomponent 12 may be practiced by withdrawing or inserting one or morebars or rods 28 into LMA component 12, where the bar or rod 28 isoperatively connected to the KIT component 14. According to one aspectof the invention, one or more rods 28, or “manipulation rods,” may bemounted to ETT component 14 and when rod 28 is moved or translated, forexample, by an attending anesthesiologist, the ETT component 14 may betranslated along LMA component 12, for example, to extend the distal end30 of KIT component 14 into or extract the distal end 30 of ETTcomponent 14 from or out of the larynx 16 and/or trachea 18 of patientP. In one aspect, bar or rod 28 may be manipulated by an automatedmanipulator, for example, by an actuator or a robotic arm end, and thelike.

FIG. 2 is a right side elevation view of intubation device to shown inFIG. 1. FIG. 3 is a top plan view of intubation device to shown in FIG.2. FIG. 4 is a bottom view of intubation device to shown in FIG. 2.Though the intubation device shown in FIGS. 1 through 4 is presented asa modification to an existing LMA device provided by Intersurgical Ltd.of Berkshire, UK, aspects of the present invention may be provided byany form of LMA device, for example, a modified existing LMA device oran LMA component specially designed and fabricated to implement aspectsof the present invention.

As shown in FIGS. 2 through 4, intubation device to includes an LMAcomponent 12 and an ETT component 14, and LMA component 12 includes abody or tube portion 22 and a mask portion 24. ETT component 14 includesan elongated hollow tube 15 having a distal end 30 and a proximal end32.

According to aspects of the invention, the ETT component 14 of device tois mounted for translation within the LMA component 12 of device to, forexample, as indicated by double arrows 39 in FIGS. 2 through 4. As shownin FIGS. 2 through 4, according to one aspect, withdrawing or insertingone or more bars or rods 28 into LMA component 12 may effect thetranslation of ETT component 14 within LMA component 12. According toone aspect of the invention, the one or more rods 28 are mounted to ETTcomponent 14 and when rod 28 is moved or translated, for example, asindicated by double arrow 39, the ETT component 14 may be moved ortranslated along LMA component 12. As shown in FIGS. 2 through 4, rod orbar 28 may include a knob or handle 37 to facilitate handling of rod 28while translating ETT component 14 within LMA component 12.

As shown in FIG. 3, according to one aspect of the invention, tube 15 ofETT component 14 may typically extend beyond the LMA component 12 adistance 27. For example, in one aspect, the distance 27 from theopening 25 in the mask portion 24 of LMA component 12, for instance,from the distal end of opening 25, may range from about 5 centimeters[cm] to about 30 cm. In one aspect, the distance 27 may range from 10 cmto 22 cm, for example, between 15 cm and 20 cm.

The opening 25 in the mask portion 24 may be circular, elliptical,rounded rectangular, or pear-shaped (as shown). In one aspect, opening25 may be elliptical or rounded rectangular and have a narrower width(that is, a narrower medial to lateral dimension) than height (that is,the antero-posterior dimension). According to one aspect, the narrowerwidth of opening 25 may function as a guide for tube 15 and facilitatethe passage of the distal end 30 of tube 15 into the trachea (or othercavity) of the patient. In one aspect, the aspect ratio (that is,height-to-width ratio) of opening 25 may range from about 1.25 to 4.0,but is typically between about 1.5 and 2.0.

According to one aspect, the translation of ETT component 14 within LMAcomponent 12 may be limited or substantially prevented by one or moreobstructions or “stops” or “extraction stops” 26, generally identifiedby arrow 26 in FIG. 2 through 4. An example of one obstruction or stop26 that may be used to limit or prevent translation of ETT component 14within LMA component 12 is shown and described with respect to FIGS. 5and 6.

FIG. 5 is a top view of intubation device to shown in FIG. 2, partiallyshown in cross section to illustrate details of an aspect of theinvention. FIG. 6 is a detail view of intubation device to shown in FIG.5, as identified by Detail 6 shown in FIG. 5. As shown in FIGS. 5 and 6,rod or bar 28 may be mounted to an extension, ring, projection, bracket,clamp, or “tab” 36 that projects from rod 28 and engages ETT component14, for example, engages hollow tube 15 of ETT component 14. Typically,projection 36 may be rigidly mounted to rod 28 and projection 36 may berigidly mounted to ETT component 14, for example, with an appropriateadhesive and/or mechanical fastener. In one aspect, projection 36 may beformed integrally with rod 28 and/or formed integrally with tube 15, forexample, integrally molded during fabrication, and then, as appropriate,mounted to rod 28 or tube 15, respectively, for example, with anadhesive or fastener.

According to one aspect of the invention, a recess, cavity, or slot 38may be provided in tube portion 22 of LMA component 12 and adapted toreceive projection 36 and/or rod 28. In one aspect, the walls of recessor slot 38 may function to guide the movement or translation ofprojection 36 and/or rod 28. As shown most clearly in FIG. 6, in oneaspect, the obstruction or stop 26 may comprise an end wall of recess orslot 38, where a surface of projection 36 contacts the end wall or stop26 to prevent further movement or transition of projection 36, and thusprevents further movement or translation of rod 28 and tube portion 15of ETT component 14.

According to one aspect of the invention, the translation of ETTcomponent 14 within LMA component 12 may be limited or substantiallyprevented by one or more obstructions or “stops” or “insertion stops”40, shown in FIG. 5. For example, insertion stop 40 may comprise an endwall of recess or slot 38, where a surface of projection 36 contacts theend wall or stop 40 to prevent further movement or transition ofprojection 36, and also of rod 28 and tube portion 15 of ETT component14.

FIG. 6A is a detail view, similar to FIG. 6, illustrating another aspectof the invention. As shown in FIG. 6A, aspects of the invention mayprovide a tactile feedback mechanism when moving or translating ETTcomponent 14 within LMA component 12. In one aspect, rod or bar 28and/or ETT component 14 may include structures that contact or interactwith other structures, for example, one or more detents, in tube portion22 of LMA component 12 that indicate to the user when a predetermineddeflection or translation of ETT component 14 within LMA component 12occurs. For example, in on aspect, tube 15 of ETT component 14 mayinclude projections or ribs 29, for example, external annularprojections or ribs 29, that contact one or more projections or ribs 31,for example, internal annular projections or ribs 31, on LMA component12, for example, along the internal surface of tube portion 22. Forinstance, in one aspect, one or both of projections 29 on tube 15 and/orprojections 31 on LMA component 14 may be flexible, for example,elastomeric, and provide at least some resistance to the passage ofprojections 29 passed projection 31. In one aspect, the inside dimensionof projections or ribs 31 may be substantially equal to or smaller thanthe outside dimension of projections or ribs 29, wherein at least somecontact or interference occurs when tube 15 is translated relative totube portion 22. The predetermined spacing between projections 29, andthus the predetermined deflection or translation of ETT component 14,may vary from 5 mm to 5 cm, but is typically about to mm (that is, about1 cm).

In another aspect, as shown in FIG. 6A, rod or bar 28 may includeprojections or ribs 33, for example, external annular projections orribs 33, that contact one or more projections or ribs 35, for example,internal annular projections or ribs 35, in LMA component 12, forexample, along the hole through which rod 28 passes. For instance, inone aspect, one or both of projections 33 on bar 28 and/or projections35 on LMA component 12 may be flexible, for example, elastomeric, andprovide at least some resistance to the passage of projections 33 passedprojection 35. In one aspect, the inside dimension of projections orribs 35 may be substantially equal to or smaller than the outsidedimension of projections or ribs 33, wherein at least some contact orinterference occurs when rod 28 is translated relative to tube portion22. The predetermined spacing between projections 33, and thus thepredetermined deflection or translation of rod 28, may vary from 5 mm to5 cm, but is typically about to mm (that is, about 1 cm). Other tactilefeedback mechanisms or detents that may be used with aspects of theinvention will be apparent to those of skill in the art.

FIG. 6B is a partial plan view of an alternate mounting of rod 28 totube 15 of ETT component 14 according to one aspect of the invention.FIG. 6C is an end view, partially in cross section, of the alternatemounting shown in FIG. 6B. As shown in FIGS. 6B and 6C manipulation baror rod 28 may be mounted to tube 15 by one or more clamps or brackets17, for example, a metal, plastic, or rubber bracket having lobes 19 and21 attached to connecting bar 23 and appropriately sized to be clampedto, to be crimped on, or mounted with an adhesive to rod 28 and tube 15,respectively

FIG. 7 is a bottom view of another intubation device 50 having a feed orextraction lumen, passage, or conduit 52, for example, a gastricdrainage port, or an orogastric port, according to one aspect of theinvention. According to this aspect, intubation device 50 may typicallycomprise an LMA component 54 having a body or tube portion 56 and a maskportion 58, and an ETT portion 60, having a tube 61, translatable withinLMA component 54, for example, by means of a rod or bar 62, as discussedherein. In the aspect of the invasion shown in FIG. 7, intubation device50 includes a conduit or lumen 52 having an open first end 64, orgastric orifice, located in the distal end of LMA component 54, forexample, in mask portion 58, and an open second end 66 located in theproximal end of LMA component 54. According to aspects of the invention,conduit or lumen 52 is located in mask portion 56 so that, when insertedover the larynx (see FIG. 1), the open first end 64 of conduit or lumen52 is positioned in fluid communication with the esophagus 20 of patientP (see FIG. 1), and is available to introduce or extract fluids, forexample, gastric fluids, from esophagus 20, if needed. In one aspect,open second end 66 of conduit or lumen 52 may be exposed to vacuum, forexample, via a conventional vacuum connector, to withdraw fluid fromesophagus 20, for example, to withdraw gastric fluids. In one aspect,conduit or lumen 52 may be referred to as “a gastric drainage port,” asknown in the art, and functions accordingly.

FIG. 8 is a top view of another intubation device 70 having a tubeinflation cuff 72 according to another aspect of the invention.According to this aspect, intubation device 70 may typically comprise anLMA component 74 having a body or tube portion 76 and a mask portion 78,and an ETT portion 80, having a tube 81, translatable within LMAcomponent 74, for example, by means of a rod or bar 82, as discussedherein. In the aspect of the invention shown in FIG. 8, intubationdevice 70 includes an inflation balloon or cuff 72 mounted to tube 81 ofETT component 80 and an inflation conduit or lumen 84 in fluidcommunication with the inside of cuff 72. According to aspects of theinvention, cuff 72 may operate and function as a conventional cuff asknown in the art, for example, cuff 72 may inflate or expand when filledwith a fluid, for example, pressurized gas, such as, air, and restrictor prevent the flow of fluid through the annular passage defined by tube81 and the cavity in which tube 81 and cuff 72 are positioned, such as,a trachea.

As shown in FIG. 8, conduit or lumen 84 from cuff 72 may pass from cuff72 along tube 81 and have an open end 86 in the proximal end of LMAcomponent 74. As shown, in one aspect, conduit or lumen 84 may beconnected to an external conduit or pipe 88 that can be connected to asource of pressurized gas, such as, air. As shown, in one aspect,conduit 88 may be operatively connected to a inflation pilot balloon 90,as known in the art, for inflating cuff 72, though any source ofpressurized gas may be used.

According to an aspect of the invention, with ETT component 80 beingtranslatable within LMA component 74, conduit or lumen 84 may be mountedon or in tube 81 of ETT component 80 and conduit or lumen 84 maytranslate with ETT component 80. For example, in one aspect, at least aportion of conduit or lumen 84 may be mounted on or in tube 81, forexample, molded into tube 81, and then a least a portion of conduit orlumen 84 may detach from or disengage from tube 81 and be mounted to rodor bar 82. In one aspect, at least a portion of conduit or lumen 84 maybe molded into rod or bar 82. Accordingly, in one aspect, conduit ortube 84 may exit LMA portion 74 through the same opening as the rod 82exits LMA component 74.

FIG. 9 is a front end view of an intubation device too according to oneaspect of the invention. As shown in FIG. 9, in this aspect, intubationdevice 100 may typically comprise an LMA component 104 having a body ortube portion 106 and a mask portion 108, and an ETT component (notshown) translatable within LMA component 104, for example, by means of arod or bar 110, as discussed herein. As shown in FIG. 9, in a typicalaspect, body portion 106 of LMA component 104 may include an appropriateconnector 112 adapted to accept conventional conduits (not shown) andconnector 112 may be placed in fluid communication with the internalpassage 114 of LMA component 104.

As also shown in FIG. 9, LMA component 104 may include one or more lumenor conduits 116 having open ends 118. The one or more lumen or conduits116 may communicate with an inflatable cuff, for example, cuff 72 shownin FIG. 8, or inflatable balloon 202 shown in FIGS. 16, 17, and 18, oran inflatable cuff associated with mask portion 108. According toaspects of the invention, open ends 118 of lumen or conduit 116 may belocated anywhere on the proximal end of body 106, including on the sidesof body 106 or anywhere about the end of body 106, for example, on anysurface of body 106 outside of connector 112.

As also shown in FIG. 9, inflation lumen or conduit 120 may beassociated with bar or rod 110 and exit body 106 via the same opening122 through which bar or rod 110 exits body 106. However, in anotheraspect, inflation lumen or conduit 120 may exit body 106 via a differentopening from which bar or rod 110 exits body 106. As also shown in FIG.9, inflation lumen or conduit 120 may communicate with external conduit124 and with an inflation pilot balloon 126, as known in the art.

FIG. 10 is a rear end view of the intubation device 50 shown in FIG. 7having a feed or extraction lumen, passage, or conduit 52, for example,a gastric drainage port, according to one aspect of the invention.According to this aspect, intubation device 50 may typically comprise anLMA component 54 having a body or tube portion 56 and a mask portion 58,and an ETT portion 60, having a tube 61.

FIG. 11 is a partial right side elevation view of an intubation device130 having an extension 132 having an extended feed or extraction lumen,passage, or conduit 134, for example, a gastric drainage port, accordingto another aspect of the invention. FIG. 12 is a partial bottom view ofthe intubation device 130 shown in FIG. 11.

According to this aspect, as is typical of aspects disclosed herein,intubation device 130 may typically comprise an LMA component 136 havinga body or tube portion 138 and a mask portion 140, and an ETT component141 (shown in phantom in FIG. 11) translatable within LMA component 136,as discussed herein.

As shown in FIGS. 11 and 12, in this aspect, the mask portion 140 of LMAcomponent 136 of intubation device 130 may include an extension 132having an orifice or opening 133, or orogastric orifice, and a lumen,passage, or conduit 134 in fluid communication with lumen or conduit 135in LMA component 136. According to this aspect, the extension 132 havingthe opening 133 may be adapted to extend, for example, to extend fromthe location of conventional LMA mask, wherein, when inserted into apatient, extension 132 is capable of extending into the esophagus, forexample, into the upper esophagus. It is envisioned that extension 132may possibly extend near or into the stomach. In one aspect, theextension 132 having conduit 134 may provide closer access to thestomach than prior art intubation devices.

In one aspect, intubation device 130 may extend a distance 142 beyondthe length or extent of a conventional LMA (shown in phantom in FIG.12). Distance 142 may be at least to millimeters [mm] longer than thelength of a conventional LMA. In one aspect, the distance 142 may be atleast 20 mm longer, or at least 30 mm longer, or at least 50 mm longerthan conventional devices.

In the aspect of the invention shown in FIGS. 11 and 12, extension 132is generally depicted in the shape of a truncated frustum, that is,narrowing or tapering while extending from mask portion 140. However, itis envisioned that extension 132 having opening 133 and lumen, conduit,or passage 134 may assume a broad range of shapes and geometries whileproviding the desired function. In one aspect, extension 132 may becylindrical in shape, for example, circular cylindrical, ellipticalcylindrical, or polygonal cylindrical. In one aspect, the cylindricalshape of extension 132 may taper while extending from mask portion 140,as in the tapered shape shown in FIG. 12. For instance, in one aspect,extension 132 may comprise a hollow cylinder, for example, a circular ornon-circular tube extending from, for example, mask portion 140, andinto the esophagus, and possibly extending even to the stomach. Othershapes and geometries for extension 132 which provide the desiredfunction will be apparent to those of skill in the art while notdeviating from the operations and functions of the disclosed invention.

FIG. 13 is a partial top view of an intubation device 150 having a maskportion 152 with surface corrugations or projections 154 according toanother aspect of the invention. FIG. 13A is a partial side elevationview of the intubation device 150 shown in FIG. 13 as viewed along viewdirection 13A shown in FIG. 13. FIG. 14 is a partial right sideelevation view of the intubation device 150 shown in FIG. 13. Intubationdevice 150 may typically include an LMA component 158 having a body ortube portion 160 and mask portion 152, and an ETT component (not shown)translatable within LMA component 158, for example, by means of a rod,as disclosed herein.

As shown in FIGS. 13, 13A, and 14, in this aspect of the invention, atleast a portion of a surface 162 of LMA mask portion 152 comprises aplurality of corrugations or projections 154 that extend above surface162 and define a plurality of recesses, depressions, or “valleys” 156between or about projections 154. According to one aspect of theinvention, projections 154 and recesses 156 provide at least somereduction in the area of contact between the surface 162 of mask portion152 and the surface of the tissue contacted by mask portion 152, forexample, the laryngeal mucosa. According to aspects of the invention, itis believed that contact, for example, substantially uniform contact,between the surface 162 of mask portion 152 with the mating surface ofthe tissue and the consequent compression of the surface of the matingtissue may undesirably reduce blood circulation in the area contactedand compressed. For example, the potential for restricting blood flowmay be exacerbated when a mask portion 152 contacts the tissue for anextended period of time, for example, while the patient is undergoingsurgery. According to aspects of the invention, it is believed that thereduction of the contact area between surface 162 and the contactedtissue may limit or prevent restricting blood flow in or about thetissue contacted by intubation device 150. For example, it is believedthat the depressions or “valleys” 156 between or around projections 154may not expose the mating tissue surface to contact and compression, andthus desirably not limit blood flow in the areas of the depressions orvalleys 156.

According to one aspect of the invention, projections or corrugations152 may cover only a portion of the surface 162 of mask portion 152, forexample, projections or corrugations 152 may extend over portions ofsurface 162 that are more likely to limit compression and not diminishblood flow in the mating tissue. In one aspect, projections orcorrugations 152 may define an annular region about surface 162, forexample, where a portion of surface 162 inside and/or outside theannular region of surface 162 is devoid of projections or corrugations152.

As shown most dearly in FIG. 13A, in one aspect, projections orcorrugations 154 may be curved, for example, circular or semicircular inshape, for example, having a radius ranging from about 1 mm to about 50mm. In other aspects, projections or corrugations 154 may becurvilinear, for example, having planar and/or non-planar surfaces. Forexample, in one aspect, projections or corrugations 154 may be polygonalin cross section, for example, defining planar surfaces, convergingpoints or apexes, rounded apexes, or pyramidal structures adapted tocontact the mating tissue surface. Other effective shapes forprojections 154 will be apparent to those of skill in the art.

The height or elevation of projections 154 above surface 162 may rangefrom about 1 mm to about 25 mm, but may typically be between about 5 mmand about 15 mm in height above surface 162. The widths or diameters ofprojections 154 may range from about 1 mm to about 25 mm, but maytypically be between about 5 mm and about 15 mm in width or diameter. Inone aspect, the dimensions of projections or corrugations 154 may vary;for example, adjacent projections 154 may have varying heights abovesurface 162, and/or varying widths, and/or varying diameters, and/orvarying radii.

FIG. 15 is a front end perspective view of an intubation device 170having an LMA component 172 having a sealing device 174 for themanipulation or tube-translating rod or bar 176, as discussed herein,according to another aspect of the invention. Intubation device 170 maytypically include an LMA component 172 having a body or tube portion 178and passages or lumen 177 as disclosed herein, and a mask portion (notshown), and an ETT component (not shown) translatable within LMAcomponent 172, for example, by means of a rod 176, as disclosed herein.In one aspect, two or more sealing devices or elements 174 may beprovided on one or more rods 176.

As shown in FIG. 15, in this aspect, rod or bar 176 includes some formof sealing device or element 174 adapted to at least partially seal theannular space 180 about the outside surface of rod 176 and the insidesurface of hole 182—through which rod 176 passes—to limit or prevent thepassage of fluids. In one aspect, as indicated by double arrow 184,sealing element 174 may be adapted to translate along rod 176, forexample, to vary the location of sealing element 174 while rod 176 isreciprocated within hole 182. In one aspect, sealing element 174 mayalso be rotatable about rod 176. In one aspect, sealing element 174 maybe substantially fixed on rod 176, for example, to ensure engage ofsealing element 174 with hole 182 when rod 176 is positioned in apredetermined position. In one aspect, sealing element 174 on rod 176may be positioned within LMA component 172 and at least partially sealthe annular space 180 between the inside surface of hole 182 and theoutside surface of rod 176.

In the aspect of the invention shown in FIG. 15, sealing element 174 isfrusto-conical in shape, for example, having a smaller diameter directedtoward hole 182. However, according to aspects of the invention, sealingelement 174 may comprise any conventional shape adapted to seal theannular space 180, for example, depending upon the shape of annularspace 180. For example, in one aspect, sealing element 174 may not becircular and may not be conical and provide the desired sealingfunction.

In one aspect, sealing element 174 may be at least partially made froman elastomeric or “rubber” material, for example, where sealing element174 may at least partially elastically deform when engaging hole 182 toprovide a resilient seal. In one aspect, sealing element 174 maycomprise at least a portion made from a natural polymer, such as,polyisoprene rubber, or a synthetic polymer, such as, a neoprene, athermoplastic elastomer, a thermoplastic rubber, and a polyvinylchloride, or an ethylene propylene diene monomer (EPDM) rubber, and thelike. In one aspect, sealing element 174 may be fabricated entirely froman elastomeric material, for example, one or more of the abovematerials.

FIG. 15A is an elevation view of a front end of intubation device 170shown in FIG. 15 having translation indicia 175 on the tube-translatingrod or bar 176 according to another aspect of the invention. As shown inFIG. 15A, in this aspect, intubation device 170 having an LMA componentincludes one or more indicia 175 reflecting or indicating thetranslation of the tube-translating rod or bar 176, as discussed herein.Intubation device 170 may typically include an LMA component 172 havinga body or tube portion 178 and passages or lumen 177 as disclosedherein, and a mask portion (not shown), and an ETT component (not shown)translatable within LMA component 172, for example, by means of a rod176, as disclosed herein.

As shown in FIG. 15A, indicia 175 may include lines or notches or otherindicia in or on the surface of rod 176, wherein movement or translationof rod 176 (and thereby translation of an ETT component (not shown) towhich rod 176 is mounted) is indicated by the relative deflection ofindicia 175 on rod 176. Though the movement of indicia 175 may bevisually detected in comparison to the position (for example, arelatively stationary position relative to rod 176) of any structure onLMA component 172, according to one aspect of the invention, therelative movement of rod 176 indicated by indicia 175 may be indicatedrelative to the end surface 179 of LMA component 172, or to acorresponding indicator mounted on or in end surface 179 of LMAcomponent 172. Other indicia reflecting or indicating the translation ofthe tube-translating rod or bar 176 that may be used with aspects of theinvention will be apparent to those of skill in the art.

FIG. 16 is a partial right side elevation view of an intubation device200 having a tube deflecting balloon or cuff 202 according to anotheraspect of the invention. In FIG. 16, the cuff 202 is shown uninflated.FIG. 17 is a partial right side elevation view of intubation device 200similar to FIG. 16 with the cuff 220 shown at least partially inflated.Intubation device 200 may typically include an LMA component 204 havinga body or tube portion 206 and a mask portion 208, and an ETT component210 having a tube 212 translatable within LMA component 204, forexample, by means of a rod (not shown), as disclosed herein. In oneaspect, tube 202 may include its own cuff, for example, cuff 72 as shownand described with respect to FIG. 8. As shown in FIGS. 16 and 17, maskportion 208 may include an extension 214 having an extended feed orextraction lumen, passage, or conduit 216 as disclosed in described withrespect to FIGS. 11 and 12.

As shown in FIGS. 16 and 17, in one aspect, LMA component 204 includesone or more inflatable balloons 202 positioned and adapted to vary theposition or orientation of tube 212 of ETT portion 210. According tothis aspect, balloon 202 may be inflated by any conventional source offluid, for example, pressurized air. In one aspect, as shown in FIG. 16,balloon 220 may be inflated via one or more passages, conduits, or lumen203 operatively connected to a source of pressurized fluid, including aliquid or a gas. In one aspect, passage, conduit, or lumen 203 maycommunicate with an opening in the proximal end of tube portion 206 ofLMA component 204, for example, one of the holes 177 shown in FIG. 15.In one aspect, balloon 202 and lumen 203 may be operatively connected toan inflation pilot balloon, for example, inflation pilot balloon 126shown in FIG. 9.

As shown most dearly in FIG. 17, in one aspect, with the at leastpartial inflation of balloon 202, tube 212 may be re-positioned, forexample, from a first position 218 (for example as shown in FIG. 16) toa second position 220 (as shown in FIG. 17), as indicated by arrow 222.FIG. 18 is a partial bottom view of intubation device 200 shown in FIG.17 as viewed along view line 18 in FIG. 17.

As shown in FIGS. 17 and 18, when at least partially inflated, balloon202 contacts and deflects tube 202, and according to one aspect, mayalso direct or orient tube 202 in a desired direction and/ororientation, for example, past the larynx and into the trachea. In oneaspect, balloon 202 may include one or more depressions or recesses 205positioned and shaped to guide the deflection of tube 212. As shown inFIG. 18, in one aspect, balloon 220 may be “kidney bean shaped” havingtwo lobes and the recess 205 between the two lobes of the “kidney bean.”For example, in one aspect, recess 205 in balloon 202 may be shaped toat least partially capture or retain tube 212 and direct tube 212 in adesired direction or orientation. It is also envisioned that in oneaspect, two or more balloons 205 may be provided, and the two or moreballoons 205 may be inflated individually or together through one ormore lumen 203 to guide the positioning of tube 212. For example, in oneaspect, the lobes of the kidney bean shaped balloon 202 shown in FIG. 18may comprise individual, separate balloons 202A and 202B, each inflatedby separate lumen 203 and separate sources of pressurized fluid. In thisaspect, the separate balloons 202A and 202B may be separately inflatedand/or their inflation varied to facilitate positioning of tube 212. Itis envisioned that 3 or more balloons 202 having 1 or more feedinglumens and sources of pressurized fluid may also be used to facilitatepositioning of tube 212.

FIG. 16A is a partial right side elevation view, partially in crosssection, of an intubation device 201 having a tube guiding structure 207according to another aspect of the invention. Intubation device 201 maytypically include an LMA component 209 having a body or tube portion 211and a mask portion 213, and an ETT component 215 having a tube 217translatable within LMA component 209, for example, by means of a rod(not shown), as disclosed herein. According to this aspect of theinvention, any one of the mask portions disclosed herein may include astructure 207, for example, an incline or a ramp, positioned andoriented to facilitate the passage of tube 217 through the opening inmask portion 213. In one aspect, structure 207 may be a plate or panelhaving a planar surface oriented to receive and direct tube 217 throughmask portion 213. In another aspect, structure 207 may be a plate orpanel having a curvilinear or radiused surface oriented to receive anddirect tube 217 through mask portion. In a further aspect, structure 217may comprise a surface of the internal passage through mask portion 213that is a planer, a curvilinear, or a radiused surface oriented toreceive and direct tube 217 through mask portion.

FIG. 19 is a top view of an intubation device 250 partially shown incross section to illustrate details of the intubation device 250 havingan ETT component 254 having multiple lumens according to another aspectof the invention. As shown in FIG. 19, intubation device 250 includes anLMA component 252 and an ETT component 254, and LMA component 252includes a body or tube portion 256 and mask portion 258. As disclosedherein, ETT component 254 may be translatable within LMA component 252,for example, via rod 260. In the aspect shown in FIG. 19, ETT component254 includes an elongated hollow tube 255 having multiple passages orlumens 257 and 258. In one aspect, tube 255 includes two lumens 257 and258; however, other aspects may include 2 or more lumens, for example, 3or more lumens, or 5 or more lumens. Though lumens 257 and 258 may beprovided by individual conduits or passages, for example, conduitswithin or about tube 255, in one aspect, lumens 257 and 258 or more maybe defined by one or more septa, for example, septum or wall 260 withintube 255.

According to aspects of the invention, the multiple lumens 257 and 258associated with tube 255 may be in fluid communication with externalfluid sources, for example, medication, handling, and/or treatment, suchas, a source of fluid vacuum or fluid pressure. In one aspect, themultiple lumens 257 and 258 may access external fluid sources,treatment, or handling via one or more conduits associated with rod 260,for example, as disclosed and described with respect to FIGS. 21 and 22.

FIG. 20 is a detail view of a top of an intubation device 270, similarto intubation device 250 shown in FIG. 19, having multiple lumens for,for example, bronchial isolation according to another aspect of theinvention. As shown in FIG. 20, intubation device 270 includes an LMAcomponent 272 and an ETT component 274, and LMA component 272 includes abody or tube portion (not shown) and mask portion 276, as disclosedherein. ETT component 274 may be translatable within LMA component 272,as disclosed herein. In the aspect shown in FIG. 20, ETT component 274includes an elongated hollow tube 275 (shown of indeterminate length tofacilitate illustration of this aspect of the invention) having multiplepassages or lumens 277 and 278.

Though 2 or more passages 277 and 278 may be provided, in this aspect,tube 275 may include two lumens 277 and 278, and, according to thisaspect, lumens 277 and 278 may separate (for example, bifurcate) intotwo individual lumens 277A and 278A. As shown in FIG. 20, lumens 277Aand/or 278A may have inflatable balloons or cuffs 280 and 282,respectively, which may be inflated via conduits 284 and 286,respectively. In one aspect, inflation conduits 284 and 286 may passwithin or about lumen 277A and 277 and 278A and 278, respectively, to anexternal source of pressure, as disclosed herein, for example, to apilot balloon (not shown).

According to aspects of the invention, the two-lumen intubation device270 shown in FIG. 20 may be uniquely adapted for intubation withbronchial isolation. For example, in one aspect, lumen 277A havinginflatable cuff 280 may be inserted into the trachea and into one of thebronchia of the lung of a patient, and then cuff 280 may be inflated toisolate the bronchus. While one bronchus may be isolated by lumen 277Aand inflated cuff 280, the other bronchus may be accessed via lumen 278Ato, for example, introduce or removal of fluids (including liquidsand/or gases). In one aspect, both cuffs 280 and 282 may be inflated inseparate bronchia to isolate both bronchia for treatment. In one aspect,lumen 277A and lumen 278A may be substantially the same length; however,in other aspects, lumens 277A and 278A may be of different lengths. Inone aspect, when lumen 277A and 278A are of different lengths, differentareas of the trachea and/or bronchia and/or esophagus may be isolated.For example, in one aspect, lumen 277A having a shorter length may bepositioned in the esophagus and cuff 280 may be inflated to isolate theesophagus, while lumen 278A having a longer length may be positioned ina bronchus and cuff 282 may be inflated to isolated the bronchus, forexample, simultaneously, for instance, at substantially the same time.Other combinations of length of lumens and isolation of passages will beapparent to those of skill in the art.

FIG. 21 is a top view of an intubation device 300 partially shown incross section to illustrate details of the device 300 having an ETTcomponent 304 having a conduit according to another aspect of theinvention. FIG. 22 is a detail view of the intubation device 300 shownin FIG. 21, as identified by Detail 22 shown in FIG. 21. As shown inFIGS. 21 and 22, intubation device 300 includes an LMA component 302 andan ETT component 304, and LMA component 302 includes a body or tubeportion 306 and mask portion 308. As disclosed herein, ETT component 304may be translatable within LMA component 302, for example, via rod 310.

In the aspect shown in FIGS. 21 and 22, ETT component 304 includes anelongated hollow tube 305 having one or more conduits or passages 312and one or more open ends, holes, or orifices 314 in tube 305, forexample, at the distal end of tube 305. According to aspects of theinvention, the one or more orifices or holes 314 may be provided in tube305 (for example, evenly distributed about and/or along the distal endof tube 305) and, for example, one or more of the orifices maycommunicate with one or more conduits 312. According to aspects of theinvention, the one or more conduits or passages 312 and one or more openends 314 may be used to introduce or extract one or more fluids to orfrom a trachea, a bronchus, an esophagus, or another cavity or passageinto which tube 305 is placed. The one or more conduits or passages 312may communicate with external sources, for example, sources ofmedication, or treatments, for example, vacuum or fluid pressure, byconventional means.

As shown most clearly in FIG. 22, in one aspect, the one or moreconduits or passages 312 may communicate with external sources ortreatments via one or more conduits that are associated with rod 310. Inone aspect, rod 310 may be at least partially hollow and the internalopening in hollow rod 310 may be in fluid communication with conduits orpassages 312.

As shown in FIG. 22, in one aspect, conduit 312 may communicate with aconduit, passage, or lumen 316 associated with rod 310, for example,mounted to rod 310, comprise a hollow rod 310, and/or extend along rod310. In one aspect, conduit 316 may translate with rod 310, forinstance, as rod 310 and rod projection 311 translate within slot orcavity 315 of tube portion 306 of LMA component 302. In another aspect,conduit 312 may translate with tube 305 and translate with rod 310. Inone aspect, conduit 316 and rod 310 may exit tube portion 306 of LMAcomponent 302 via the same opening in LMA component 302. As shown inFIG. 22, conduit 312 may communicate with conduit 316 via a transitionconduit 318, for example, a conduit that conducts fluid from conduit 312to conduit 316. In one aspect, conduits 312, 316, and 318 may beintegrally formed, for example, integrally molded, when forming tube 305and/or projection 311 and/or rod 310.

As shown in FIG. 21, conduit 316 may exit LMA component 302 and bedirected and handled as needed. In one aspect, conduit 316 may be usedas a pathway for introducing one or more medications, as indicated bysyringe 320 shown in FIG. 20. In another aspect, conduit 316 may be usedas a pathway for introducing or extracting a fluid or gas, for example,as indicated by pilot balloon 322 shown in FIG. 21.

In one aspect, the one or more conduits 316 may be in fluidcommunication with one or more open ends 314 of one or more conduits orlumens 312 and provide an indication of a vital sign of a patient. Forexample, in one aspect, pilot balloon 322 may comprise a sensor adaptedto detect a condition within the patient, for example, a pressure withinthe trachea, bronchia, or esophagus of the patient. In another aspect,pilot balloon 322 may be respiration-indicating device, for example, aballoon or other membrane adapted to visually deflect or visually varydepending upon the respiration of the patient. In one aspect, pilotballoon 322 may be a balloon or a membrane adapted to deflect, orinflate and deflate, with the respiration of the patient to provide avisual indication of the respiration of the patient and, for example,the variation of the respiration of the patient. Other uses of one ormore conduits 312, 316, and 318 and their fluid communication with oneor more open ends 314 in the tube 305 will be apparent to those of skillin the art.

FIGS. 23 and 24 are schematic illustrations of cross-section views of anLMA component tube portion 330 and an ETT component tube 332illustrating a restriction or stop to removing the ETT component tube332 from LMA component tube portion 330 according to one aspect of theinvention. LMA component tube portion 330 and an ETT component tube 332may comprise components of any one of the intubation devices disclosedherein. Though not shown in FIGS. 23 and 24, LMA component 330 maytypically have all the attributes of the LMA components disclosedherein, for example, a mask portion (not shown) and ETT component tube332 may have all the attributes of the ETT components disclosed herein.

As disclosed herein, according to one aspect of the invention, the ETTcomponent may be prevented from being removed from the LMA component.For example, in one aspect, one or more of ETT component tube 332 andLMA component tube 330 may include a “stop” or an “extraction stop” tophysically prevent, or at least deter, removal of ETT component tube 332from LMA component tube 330. FIGS. 23 and 24 illustrate anothermechanism for preventing, or at least discouraging, removal of ETTcomponent tube (or “ETT tube”) 332 from LMA component tube (or “LMAtube”) 330 according to one aspect of the invention.

As shown in FIG. 23, in this aspect, LMA tube 330 may have a varying ortapering internal dimension, for example, a varying inside diameter,that varies from a first, larger dimension at a first end 334 to asecond, smaller dimension at a second end 336. Also, ETA tube 332 has atapering external dimension, for example, a tapering outside diameterthat varies from a first larger dimension at a first end 338 to a secondsmaller dimension at a second end 340. According to aspects of theinvention, ETA tube 332 may typically be translatable within LMA tube330, for example, by rod 342 mounted to ETT tube 332 via projection 344,as disclosed herein.

According to this aspect of the invention, removal of ETT tube 332 fromLMA tube 330 is prevented, that is, prevented under expected conditionof use, by interference between the external surface of ETT tube 332with internal surface of LMA tube 330.

In the aspect of the invention shown in FIG. 23, ETT tube 332 ispositioned in a first position relative to LMA tube 330, for example,where ETT tube 332 may freely translate within LMA tube 330. In FIG. 24,ETT tube 332 is positioned in a second position relative to LMA tube 330where ETT 332 has been translated in the direction indicated by arrow346, and the external surface of ETT tube 332 contacts the internalsurface of LMA tube 330, as indicted at 348. According to aspects of theinvention, this contact at 348 prevents the removal of ETT tube 322 fromLMA tube 330 in the direction of arrow 346.

The dimensions of ETT tube 332 and LMA tube 330 to effect this desiredaspect of the invention will be apparent to those of skill in the art inview of the typical dimensions of aspects of the invention disclosedherein.

FIG. 25 is a partial perspective view, partially in cross section, of anintubation device 400 having a rotatable endotracheal tube (KIT)component 402 mounted for translation and/or rotation within a laryngealmask airway (LMA) component 404 according to another aspect of theinvention. According to aspects of the invention, intubation device 400,ETT component 402, and LMA component 404, and any intubation device, ETTcomponent, and LMA component disclosed herein, may have one or more ofthe attributes of the intubation devices, ETT components, and LMAcomponents disclosed and described with respect to FIGS. 1 through 24.For example, intubation device 400 may have one or more of the featuresand functions of intubation device to, 50, 70, too, 130, 150, 170, 200,250, 270, and 300 shown in FIGS. 1 through 24. Many details ofintubation device 400 that are disclosed in FIGS. 1 through 24 areomitted here to avoid repetition and to facilitate disclosure of aspectsof the invention.

As shown in FIG. 25, as is typical of the art, the laryngeal mask airway (LMA) component 404 is adapted to be inserted into a patient and“mask” the larynx of the patient to isolate the trachea, for example, asshown in FIG. 1. The isolation of the trachea (or “windpipe”) thenpermits the ETT component 402 to pass into the trachea, and, forexample, avoid the esophagus. The LMA component 404 may typicallyinclude a tube portion 406 and a mask portion (not shown in FIG. 25)having an opening, or internal opening, for passing ETT component 402into, for example, the trachea.

According to aspects of the invention, the ETT component 402 of device400 may be mounted for translation within the LMA component 404 ofdevice 400, and the ETT component 402 of device 400 may be mounted forrotation within the LMA component 404. As disclosed and described withrespect to FIGS. 1 through 24, according to aspects of the invention,ETT component 402 may be prevented, for example, substantially preventedduring use, from being removed or extracted from the LMA component 404.As shown in FIG. 25, intubation device 400 may typically include one ormore appropriate connectors 408 adapted to accept conventional conduits(not shown) and connector 408 may be placed in fluid communication withthe internal passage of ETT component 402 and/or LMA component 404.

As disclosed herein, though many different means may be provided fortranslating, rotating, and substantially preventing extraction orremoval of ETT component 402. In one aspect, as shown in FIG. 25, device400 includes one or more bars or rods 410 operatively connected to ETTcomponent 402, and providing a mechanism for rotating ETT component 402in LMA component 404. Bar or rod 410 may include some form of handle orknob 411 adapted to facilitate manipulation, for instance, rotationand/or translation, for example, manual manipulation by an attendinganesthesiologist. In one aspect, bar or rod 410 may be manipulated by anautomated manipulator, for example, by an actuator or a robotic arm end,and the like. According to one aspect of the invention, one or moremanipulation rods 410 may be mounted to ETT component 402 and whenmanipulation rod 404 is translated and/or rotated, for example, by anattending anesthesiologist, the ETT component 402 may be translatedand/or rotated within LMA component 404, for example, to vary thealignment or orientation of the distal end (not shown) of ETT component402. A typical rotation of rod 410 and ETT component 402 is illustratedschematically by double arrow 412 shown in FIG. 25. In one aspect, oneor more manipulation bars or rods 410 may provide a mechanism fortranslating ETT component 402 in LMA component 404, for example, axiallytranslating, for instance, translating the ETT component 402 into orextracting the distal end (not shown) of ETT component 402 from or outof the larynx and/or trachea of a patient. A typical translation ofmanipulation rod 410 and ETT component 402 is illustrated schematicallybe double arrows 414 shown in FIG. 25.

As shown in FIG. 25, the distal end of manipulation rod 410 is mountedto ETT component 402 whereby the ETT component 402 moves with themovement, rotation, and/or translation of rod 410. According to aspectsof the invention, the mounting or attachment of rod 410 to ETT component402 may be effected by any conventional means, for example, mechanicalfasteners, an adhesive, or the like. In the aspect of the inventionshown in FIG. 25, the distal end of rod 410 is mounted to ETT component402 by means of a projection, a bar, a tab, a bracket, a clamp, or aplate 416 mounted to both rod 410 and to ETT component 402. In oneaspect, bar 416 may be mounted to rod 410 and also mounted to ETTcomponent 402 by any conventional means, for example, mechanicalfasteners or an adhesive. In one aspect, bar 416 may be molded or formedwith rod 410 or with ETT component 402, and then mounted to thecorresponding component by conventional means. For example, in oneaspect, rod 410 and bar 416 may be fabricated as a single integralcomponent, for example, molded, and then bar 416 may be mounted to ETTcomponent 402, for example with an adhesive. Other mountings of tab orbar 416 to rod 410 and to ETT component 402 will be apparent to those ofskill in the art.

As shown in FIG. 25, LMA component 404 may include one or more passagesor slots 418 through which rod 410 passes to engage ETT component 402.As shown in FIG. 25, slot 418 may extend an arcuate distance about theproximal end of LMA component 404, for example, subtending an angle ofat least 5 degrees, but typically at least 15 degrees, or at least 45degrees, or at least 90 degrees, or more. In one aspect, the arcuatelength of slot 418 may be greater than 90 degrees, for example, at least180 degrees, or at least 270 degrees, to provide appropriate freedom ofthe operator to rotate bar 410 and ETT component 402.

In one aspect, slot 418 may extend into the proximate end of LMAcomponent 404 to provide support, for example, radial support, for rod410 during manipulation by the user. Accordingly, in one aspect, slot418 may have a depth or height sufficient to support rod 410 duringmanipulation, for example, slot 410 may have a depth at least 5 timesthe width or diameter of bar 410, or at least to times the width ordiameter of bar 410. As shown in FIG. 25, slot 418 may have a width atleast about as equal to the width or diameter of rod 410. For example,in one aspect, the width of slot 418 may be slightly greater than thediameter or width of rod 410. In another aspect, the width of slot 418may be about equal to or slightly less than the diameter or width of rod410, for example, to provide a relatively “snug” fit between rod 410 andslot 418, such that at least the user provides some resistance to themovement of rod 410 to enhance control and operation. In one aspect,detents or projections may be provided on the surface of rod 410 and/oron the internal surface of slot 418 to provide, for example, at leastsome tactile feedback to the user when rotating rod 410 in slot 418.

As also shown in FIG. 25, the proximal end of LMA component 404, and anyLMA component disclosed herein, may typically include a conduit or tube420 adapted to engage ETT component 402. For example, conduit 420 may bea conduit or tube in fluid communication with connector 408 and extendfrom connector 408 into engagement with ETT component 402. In oneaspect, as shown in FIG. 25, conduit 420 may be larger in dimension, forexample, larger in internal diameter or internal width, than ETTcomponent 402, where ETT component 402 fits into conduit 420. However,in other aspects, conduit 420 may be smaller in dimension, for example,smaller in external diameter or external width, than ETT component 402,where conduit 420 fits into ETT component 402. According to aspects ofthe invention, ETT component 402 typically may translate and/or rotatewith respect to conduit 420, while minimizing or preventing fluidleakage from between conduit 420 and ETT component 402. One aspect ofthe invention for minimizing or prevention fluid leakage between conduit420 and ETT component 402 is shown and describe with respect to FIGS. 30and 31 below.

FIG. 26 is a partial perspective view, partially in cross section,similar to FIG. 25, where the rotatable ETT component 402 is rotatedfrom the position shown in FIG. 25, for example, a first position, tothe position shown in FIG. 26, for example, one or more secondpositions, according to one aspect of the invention. As shown in FIGS.25 and 26, with the rotation of rod 410 within slot 418, for example, bymanual manipulation of knob 411, the rotation of rod 410 rotates ETTcomponent 402, including the distal end of ETT component 402 (notshown), from the first position shown in FIG. 25 to the two or moresecond positions shown in FIG. 26. According to aspects of theinvention, it is understood that the rotation of ETT component 402 byaspects of the invention, with or without the translation of ETTcomponent 402, may provide effective means of varying the orientationand/or position of the distal end of ETT component 402 to facilitateinsertion and use of ETT component 402, for example, to avoid contact orobstruction from bodily structures, such as, the larynx.

FIG. 27 is a partial perspective view, partially in cross section, of anintubation device 430 similar to intubation device 400 having atranslatable endotracheal tube (ETT) component 432 according to oneaspect of the invention. Similar to intubation device 430 shown in FIGS.25 and 26, intubation device 430 includes an LMA component 434 having atube portion 436 and a mask portion (not shown in FIG. 27), a conduit438 adapted to engage (ETT) component 432, and one or more rods or bars440 passing through one or more holes 441 of LMA component 434 andattached to ETT component 432. According to this aspect of theinvention, manipulation of rod 440, for example, rotation and/ortranslation, effects corresponding rotation and/or translation of ETTcomponent 432. In the aspect of the invention shown in FIG. 27, LMAcomponent 434 includes some form of sealing device 442 adapted tominimize or prevent the leakage of fluid about manipulation rod 440.

FIG. 28 is a partial perspective view, partially in cross section, of aportion of the intubation device 430 shown in FIG. 27 illustrating onesealing device 442 according to one aspect of the invention. As shown inFIG. 28, according to one aspect of the invention, sealing device 442comprises a barrier or structure 444 positioned in LMA component 434 tominimize or prevent leakage of fluid through the annular space betweenthe outside dimension of rod 440 and the inside dimension of hole 441.In one aspect, barrier or structure 444 may be elastomeric, for example,a rubber ring positioned within hole 441 and allowing passage,translation, and/or rotation of rod 440. In one aspect, hole 441 may bean elongated slot, for example, as shown in slot 418 in FIG. 25, andprovide a sealing function about rod 440 as rod 440 is rotated withinarcuate slot 418.

FIG. 29 is a partial perspective view, partially in cross section, ofanother intubation device 450 having a translatable and/or rotatableendotracheal tube (ETT) component 452 with a sealing device 460according to one aspect of the invention. Similar to intubation device430 shown in FIGS. 25 and 26, intubation device 450 includes an LMAcomponent 454 having a tube portion 456 and a mask portion (not shown inFIG. 29), a conduit 458 adapted to engage ETT component 452, and, thoughnot shown in FIG. 29, intubation device 450 may include one or more rodsor bars passing through LMA component 454 and attached to ETT component452 for translation and/or rotating ETT component 452, as disclosedherein. According to this aspect of the invention, the engagement of ETTcomponent 452 with conduit 458 includes some form of sealing device 460adapted to minimize or prevent leakage of fluid about the engagement ofETT component 452 with conduit 458.

According to one aspect of the invention, the sealing device 460 maycomprise any structure adapted to minimize or prevent fluid leakagethrough the mating surfaces of ETT component 452 with conduit 458.According to this aspect, the sealing device 460 may be adapted tosealing the mating surfaces of ETT component 452 with conduit 458 whenETT component 452 is smaller than and is received by a larger conduit458, as shown in FIG. 29, or when ETT component 452 is larger than andreceives a smaller conduit 458, as disclosed herein.

FIG. 30 is a cross-sectional view of the engagement of translatableand/or rotatable ETT component 452 with conduit 458 having sealingdevice 460 as identified by Detail 30 in FIG. 29 according to one aspectof the invention. FIG. 31 is a detailed cross-sectional view of theengagement of translatable and/or rotatable ETT component 452 withconduit 458 having sealing device 460 as identified by Detail 31 in FIG.30.

As shown in FIGS. 30 and 31, sealing device 460 may be any barriermounted between ETT component 452 and conduit 458 adapted to minimize orprevent fluid leakage between the mating surfaces. In one aspect,sealing device 460 may be mounted on ETT component 452 and bear againstconduit 458; in another aspect, sealing device 460 may be mounted onconduit 458 and bear against ETT component 452. In one aspect, sealingdevice 460 may be elastomeric, for example, a “wiper”-type seal, forinstance, made from one or more of the following elastomeric materials:a natural polymer, such as, polyisoprene rubber, or a synthetic polymer,such as, a neoprene, a thermoplastic elastomer, a thermoplastic rubber,and a polyvinyl chloride, or an ethylene propylene diene monomer (EPDM)rubber, and the like.

FIG. 32 is a front elevation view, partially in cross section, ofanother intubation device 470 having translatable and/or rotatable ETTcomponent 472 having an indicator balloon 480 according to one aspect ofthe invention. In one aspect, intubation device 470 may have amanipulation bar or rod (not shown), for example, a “push rod.”According to this aspect of the invention, indicator balloon 480 is influid communication with the distal end of ETT component 472 wherebyvariations in pressure at the distal end of ETT component 472, forexample, due to patient respiration or breathing pattern, are reflectedin variations of the shape of indicator balloon 480.

Similar to intubation devices disclosed herein, intubation device 470includes an LMA component 474 having a tube portion 476 and a maskportion 477, a conduit 478 adapted to engage ETT component 472, and,though not shown in FIG. 32, may include one or more rods or barspassing through LMA component 474 and attached to ETT component 472 fortranslating and/or rotating ETT component 472, as disclosed herein.According to this aspect of the invention, the engagement of ETTcomponent 472 with conduit 478 may include some form of sealing device(not shown) adapted to minimize or prevent leakage of fluid about theengagement of ETT component 472 with conduit 478, as disclose herein.

According to the aspect shown in FIG. 32, indicator balloon 480 may bein fluid communication with some location on or about ETT component 472and/or in fluid communication with some location on or about LMAcomponent 474, for example, in fluid communication with the distal endof ETT component 472, wherein variations in a condition, such as,pressure, within or about ETT component 472 and/or within or about LMAcomponent 474, for example, at the distal end 473 of ETT component 472and/or in the mask portion 477 of LMA component 474, are reflected invariations of the shape of indicator balloon 480. Though in one aspect,variations in a condition, for example, pressure, may be indicated byvariations in the shape of balloon 480, variations in a condition mayalso be detected by other forms of mechanical and/or electricaltransducers, such as, an appropriate sensor. As shown in FIG. 32,indicator balloon 480 may be in fluid communication with intubationdevice 470 and/or LMA component 474 via one or more conduits or hoses482. According to aspects of the invention, conduit 482 is in fluidcommutation with passages or conduits within intubation device 470, forexample, with conduit 484 shown in FIG. 32 having an open end 486 in thedistal end 473 of ETT component 472.

FIG. 33 is a detailed cross-sectional view of a portion of theintubation device 470 shown in FIG. 32 as identified by Detail 33 inFIG. 32. As shown in FIG. 33, conduit 482 from balloon 480, or a conduitor passage within intubation device 470 in fluid communication withconduit 482, is in fluid communication with conduit 484 in ETT component472. According to aspects of the invention, conduit 482 may be directeddirectly to conduit 484, or conduit 482 may be directed to conduit 484via one or more conduits or passages 485 in intubation device 470, forexample, one or more conduits 485 within ETT component 472 and/or withinLMA component 474.

FIG. 34 is a front elevation view, partially in cross section, ofanother intubation device 500 having translatable and/or rotatable ETTcomponent 502 having one or more inflatable cuffs 503 and/or 505 (shownin phantom), one or more manipulation bars or rods 510, and one or morecuff inflation balloons 520 according to one aspect of the invention.According to this aspect of the invention, intubation device 500 mayhave one or more inflation cuffs 503 adapted to inflate and assist theoperator in positioning and/or orienting the distal end of the ETTcomponent 502 within the patient and/or to at least partially seal acavity into which ETT component 502 is inserted. Intubation device 500may also have one or more inflation cuffs 505 adapted to inflate andassist the operator in positioning and/or orienting the ETT component502 within the patient, and/or adapted to seal or restrict fluid flowthrough the annular cavity between the outside of the ETT component 520and the inside of LMA component 504.

Similar to intubation devices disclosed herein, intubation device 500includes an LMA component 504 having a tube portion 506 and a maskportion 507, and a conduit 508 adapted to engage ETT component 502. Theone or more bars or rods 510 may pass through LMA component 504 andattach to ETT component 502 for translating and/or rotating ETTcomponent 502, as disclosed herein. According to this aspect of theinvention, the engagement of ETT component 502 with conduit 508 mayinclude some form of sealing device (not shown) adapted to minimize orprevent leakage of fluid about the engagement of ETT component 502 withconduit 508, as disclosed herein.

As shown in FIG. 34, the one or more manipulation rods 510 may engageLMA component 504 via one or more conduits or sleeves 512. According toone aspect, at least one of rod 510 and/or sleeve 512 may be flexible;however, in another aspect, both rod 510 and sleeve 512 may be flexible,that is, made from a bendable or pliable material, such as, a rubber ora plastic. According to one aspect, the flexibility of rod 510 and/orsleeve 512 can facilitate the manipulation and accessibility of rod 510by the operator.

As also shown in FIG. 34, the one or more cuff inflation balloons 520may be in fluid communication with LMA component 504 via one or moreconduits or tubes 522 which may be in fluid communication with the oneor more inflatable cuffs 503 and/or 505 on ETT component 502 viapassages or conduits within intubation device 500, for example, viaconduit 514 which communicates with cuff 503 in the distal end of ETTcomponent 502 and/or with cuff 505 positioned along ETT component 502 ata location within LMA component 504. In one aspect, sleeve 512 of rod510 and conduit 522 of cuff inflation balloon 520 may engage LMAcomponent 504 via a common opening or via separate openings. In oneaspect, sleeve 512 and conduit 522 be mounted or attached to each other.

FIG. 35 is a detailed cross-sectional view of a portion of theintubation device 500 shown in FIG. 34 as identified by Detail 35 inFIG. 34. As shown in FIG. 35, the one or more manipulation rods 510 mayaccess LMA component 504 via sleeve 512, or one or more sleeves orconduits attached to sleeve 512. As also shown in FIG. 35, in a fashionsimilar to the access of conduit 482 shown in FIGS. 32 and 33, conduit522 from cuff inflation balloon 520, or a conduit or passage withinintubation device 500 in fluid communication with conduit 522, is influid communication with conduit 514 in or on ETT component 502.According to aspects of the invention, conduit 522 may be directeddirectly to conduit 514, or conduit 522 may be directed to conduit 514via one or more conduits or passages 516 in intubation device 500, forexample, one or more conduits 516 within ETT component 502 and/or withinLMA component 504.

In one aspect, manipulation rod 510 may be attached to ETT component 502as disclosed herein, for example, as shown in FIGS. 25 and 26. Forexample, manipulation rod 510 may be attached to ETT component 502 viaprojection, bar, tab, or plate 518 mounted to both rod 510 and ETTcomponent 502, as disclosed herein.

FIG. 36 is another detailed cross-sectional view, similar to FIG. 35, ofa portion of the intubation device 500 shown in FIG. 34 as identified byDetail 35 in FIG. 34 according to another aspect of the invention. Asshown in FIG. 36, the one or more manipulation rods 510 may access LMAcomponent 504 via sleeve 512, or one or more sleeves or conduitsattached to sleeve 512. As also shown in FIG. 36, in a fashion similarto the access of conduit 482 shown in FIGS. 32 and 33 and similar to theaccess of conduit 516 shown in FIG. 36, conduit 522 from cuff inflationballoon 520, or a conduit or passage within intubation device 500 influid communication with conduit 522, is in fluid communication withconduit 514 in or on ETT component 502 and inflation cuff 509. Accordingto this aspect of the invention, the inflation of inflation cuff 509seals or restricts fluid flow through the annular cavity between theoutside of the ETT component 502 and the inside of LMA conduit 508.

According to aspects of the invention, conduit 522 may be directeddirectly to conduit 514 and inflation cuff 509, or conduit 522 may bedirected to conduit 514 via one or more conduits or passages 516 inintubation device 500, for example, one or more conduits 516 within ETTcomponent 502 and/or within LMA component 504.

In one aspect, the structure illustrated by inflation cuff 509 in FIG.36 may comprise any restriction or sealing element adapted to seal orrestrict fluid flow through the annular cavity 511 between the outsideof the ETT component 502 and the inside of LMA conduit 508. For example,in one aspect, the structure identified as inflation cuff 509 may not bean inflation cuff but may be a flexible sealing element, for example,similar or identical to sealing device 460 shown in FIGS. 30 and 31and/or an O-ring type seal, as known in the art. In another aspect, thestructure identified, as inflation cuff 509 may be a flexiblefluid-filled device adapted to seal or restrict fluid flow through theannular cavity 511, for example, a viscous fluid or a gel-like fluidadapted to provide at least some restriction to the flow of fluidthrough the annular cavity 511.

In one aspect, manipulation rod 510 may be attached to ETT component 502as disclosed herein, for example, as shown in FIGS. 25 and 26. Forexample, manipulation rod 510 may be attached to ETT component 502 viaprojection, bar, tab, or plate 518 mounted to both rod 510 and ETTcomponent 502, as disclosed herein.

FIG. 37 is a perspective view of an end portion of the intubation device500 shown in FIG. 34 showing the engagement of the manipulation rod 510and the cuff inflation balloon 520 with the intubation device 500according to one aspect of the invention. As shown in FIG. 37, the oneor more manipulation rods 510 may access LMA component 504 viamanipulation rod sleeve, or “guide sleeve,” 512 and conduit 522 fromcuff inflation balloon 520 is in fluid communication with conduit 514(not shown).

FIG. 38 is a detailed cross-sectional view of a portion of themanipulation rod sleeve, or “guide sleeve,” 512 having a sealing device513 shown in FIG. 37 as identified by Detail 38 in FIG. 37. As shown inFIG. 38, in one aspect, sleeve 512 and/or rod 510 may include some formof sealing device 513 adapted to minimize or prevent the passage offluids between the inside diameter of sleeve 512 and the outsidediameter of rod 510.

As shown in FIG. 38, sealing device 513 may be any barrier mountedbetween rod 510 and sleeve 512 adapted to minimize or prevent fluidleakage there between. In one aspect, sealing device 513 may be mountedon rod 510 and bear against sleeve 512; in another aspect, sealingdevice 513 may be mounted on sleeve 512 and bear against rod 512. In oneaspect, sealing device 513 may be elastomeric, for example, a“wiper”-type seal, for instance, made from one or more of the followingelastomeric materials: a natural polymer, such as, polyisoprene rubber,or a synthetic polymer, such as, a neoprene, a thermoplastic elastomer,a thermoplastic rubber, and a polyvinyl chloride, or an ethylenepropylene diene monomer (EPDM) rubber, and the like.

FIG. 39 is a partial perspective view, partially in cross section, ofanother intubation device 530 having a translatable and/or rotatable ETTcomponent 532 and having a manipulation rod 540 according to one aspectof the invention. FIG. 40 is a side elevation view of the partialperspective view of the intubation device 530 shown in FIG. 39 as viewedalong view lines 40-40 shown in FIG. 39.

As shown in FIGS. 39 and 40, as in similar aspects disclosed herein,intubation device 530 includes an LMA component 534 having a tubeportion 536 and a mask portion (not shown), and a conduit 538 adapted toengage ETT component 532. In the aspect shown in FIGS. 39 and 40,instead of one or more relatively thin bars or rods adapted to may passthrough LMA component 534 and attach to ETT component 532 fortranslating and/or rotating ETT component 532, intubation device 530includes one or more larger rods or “buttons” 540 adapted to passthrough LMA component 534 and attach to ETT component 532 fortranslating and/or rotating ETT component 532. According to this aspectof the invention, the relatively larger rods or “buttons” 540 mayfacilitate access and manipulation, for example, “push button”manipulation, for example, translation, of ETT component 532 within LMAcomponent 534. Though not shown FIGS. 39 and 40, the larger rod or“button” 540 may include some form of sealing device (not shown) adaptedto minimize or prevent leakage of fluid about the engagement of rod 540within LMA component 534, as disclose herein, for example, in a fashionsimilar to the sealing device shown in FIGS. 30 and 31. In one aspect,rod 540 may be elliptical in cross section, as shown in FIGS. 39 and 40;however, it is envisioned that rod 540 may comprise any cylindricalshape, including elliptical cylindrical, circular cylindrical, andpolygonal cylindrical, among other cylindrical shapes.

As shown must clearly in FIG. 40, rod 540 may be an elongated rod and bemounted for deflection within LMA component 534 and engage ETT component532. Consistent with other aspects of the invention disclosed herein,deflection of rod 540, for example, deflection into LMA component 534 orextraction from LMA component 534, correspondingly deflects ETTcomponent 532 wherein the distal end (not shown) of ETT component 532can be inserted into or extracted from the throat of the patient. In oneaspect, one or more structures 541 (shown in phantom), for exampleprojections, recesses, or indentations, may be provided on rod 540 tofacilitate handling and/or manipulation of rod 540, for example, tofacilitate extraction of rod 540 from LMA component 534.

According to aspects of the invention, the mounting or attachment of rod540 to ETT component 532 may be effected by any conventional means, forexample, mechanical fasteners or an adhesive, and the like. In theaspect of the invention shown in FIGS. 39 and 40, the distal end of rod540 may be mounted to ETT component 532 by means of a projection, a bar,a tab, a bracket, a clamp, or a plate 542 mounted to both rod 540 andETT component 532. In one aspect, bar 542 may be mounted to rod 540 andto ETT component 532 by any conventional means, for example, mechanicalfasteners or an adhesive. In one aspect, bar 542 may be molded or formedwith rod 540 or with ETT component 532, and then mounted to thecorresponding component by conventional means. For example, in oneaspect, rod 540 and bar 542 may be fabricated as a single integralcomponent, for example, molded, and then bar 542 may be mounted to ETTcomponent 532, for example, with an adhesive. Other mountings of bar 542to rod 540 and to ETT component 432 will be apparent to those of skillin the art.

In one aspect, as shown in FIGS. 39 and 40, intubation device 530 mayinclude one or more inflation cuffs and one or more corresponding cuffinflation balloons and/or one or more indicator balloons, as indicatedby phantom by balloon 544 (shown in phantom) in FIG. 39. Balloon 544 maybe similar in design and function to cuff inflation balloon 520 shown inFIG. 34. Balloon 544 may be similar in design and function to indicatorballoon 480 shown in FIG. 32. Whether balloon 544 is a cuff inflationballoon or a indicator balloon, balloon 544 may typically be in fluidcommunication with LMA component 434 via conduit or conduit 546 (shownin phantom), and, depending upon the function of balloon 544, conduit546 may be in fluid communication with a passage or conduit 548 of ETTcomponent 532 or a passage in LMA component 534. Passage or conduit 548of ETT component 532 may extend to an inflatable cuff (not shown) on ETTcomponent 531 and/or to an open end, for example, at the distal end (notshown) of ETT component, depending upon the function of balloon 540. Asshown most clearly in FIG. 40, passage or conduit 546 may communicatewith passage or conduit 548 across plate 542 as disclosed herein.

FIG. 41 is a front view of an intubation device 550 having animage-capturing device 560 and an image-capturing device access conduitor tube 562 according to an aspect of the invention. As in similaraspects disclosed herein, intubation device 550 includes an ETTcomponent (not shown), an LMA component 554 having a tube portion 556and a mask portion 557, and a conduit (not shown) adapted to engage theETT component, as disclosed herein.

As shown in FIG. 41, intubation device 550 may typically include one ormore image capturing apertures 561, one or more wires or cables 562, forexample, a fiber optic cable, adapted to transmit signals correspondingto the images captured by the aperture 561 to image capturing device560, and one or more passages or conduits 563 adapted to receive wire orcable 562. The images captured may be still or moving images. Imagecapturing device 560 may be any device adapted to receive and store,locally or remotely, signals associated with the images captured bycable 561. Image capturing aperture 561, cables 562, and image capturingdevice 560 may be adapted to capture images in the visual spectrum, orin any range of the electromagnetic spectrum desired, including x-rayimages, infrared images, and microwave images, and the like.

According to aspects of the invention shown in FIG. 41, intubationdevice 550 may include one or more image capturing apertures 561 and oneor more passages 563 positioned anywhere images are desired to becaptured. Image capturing apertures 561 and passages or conduits 563 maybe located in the ETT component (not shown) and/or may be located withinLMA component 554, as desired.

According to aspects of the invention one or more image-capturingapertures 561 may be positioned in the distal end of the LMA component544 and/or positioned in the distal end of an ETT component (not shown).The images captured may be transmitted wirelessly or by wire to imagecapturing device 560. The images captured may be displayed locally forimmediate feedback on treatment or operation of aspects of theinvention, or stored locally or remotely for future review.

FIG. 42 is a front view of an intubation device 570 having an inflatableendotracheal tube (ETT) balloon cuff 580 and a cuff inflation balloon582 according to an aspect of the invention. As in similar aspectsdisclosed herein, intubation device 570 includes an ETT component 572(shown in phantom), an LMA component 574 having a tube portion 576 and amask portion 577 having a mask portion opening 579, and a conduit (notshown) adapted to engage the ETT component 572, as disclosed herein.According to this aspect of the invention, inflatable balloon cuff 580positioned within or about mask portion opening 579 provides a means formanipulating the passage of the ETT component 572 through or aboutinflatable balloon cuff 580. For example, in one aspect, inflation ofinflatable balloon cuff 580 or inflation of a portion of inflatableballoon cuff 580 may assist the anesthesiologist in properly and/oraccurately positioning the distal end of ETT component 572 within thepatient.

As shown in FIG. 42, intubation device 570 may typically include one ormore inflation balloons 582 adapted to inflate one or more balloon cuffs580 and/or one or more portions of balloon cuff 580 to assist inpositioning the ETT component 572. The one or more inflation balloons582 may each typically be in fluid communication with balloon cuff 580or a portion of balloon cuff 580 via one or more tubes or conduits 584.Conduit 584 may communicate directly with balloon cuff 580 or with aportion of balloon cuff 580, or communicate with balloon cuff 580 orwith a portion of balloon cuff 580 via one or more conduits or passages573 within intubation device 570, for example, within LMA component 574.For example, in one aspect, two or more cuff inflation balloons 582 maybe in fluid communication with two or more balloon cuff 580 or two ormore portions of balloon cuff 580 to allow the user to vary theinflation of the two or more balloon cuff 580 or the two or moreportions of balloon cuff 580 to vary the position and/or orientation ofETT component 572 within opening 579 and correspondingly within thepatient.

FIG. 43 is a front view of an intubation device 600 having body cavities610 and surface protrusions 620 according to an aspect of the invention.According to this aspect of the invention, body cavities 610 may reducethe weight of intubation device 600 and/or the amount of material ofintubation device 600 compared to an intubation device not having bodycavities 610. In addition, surface protrusions or surface “corrugations”620 may provide a means for stimulating or “massaging” body surfaces tofacilitate insertion and removal of intubation device 600. FIG. 44 is apartial side elevation view of the intubation device 600 shown in FIG.43, and FIG. 45 is a partial rear elevation view of the intubationdevice 600 shown in FIGS. 43 and 44.

As shown in FIGS. 43-45, intubation device 600 may include an ETTcomponent (not shown), an LMA component 604 having a tube portion 606and a mask portion 607 having a mask portion opening 609, and a conduit(not shown) adapted to engage the ETT component, as disclosed herein.According to this aspect of the invention, LMA component 604 includes aplurality of internal cavities or voids 610 that may be located withinLMA component 604 to limit the amount of material, for example, theamount of silicone rubber, required to fabricate LMA component 604, and,possibly, reduce the weight of LMA component 604, while not negativelyaffecting the desired structural strength and/or stiffness of LMAcomponent 604.

Internal cavities or voids 610 may be located within tube portion 606and/or within mask portion 607, and may vary in shape and size toprovide the desired weight reduction and/or material reduction. As shownin FIG. 43, internal cavities or voids 610 may be spherical in shape,but any three dimension shape that is conducive to the size and strengthof LMA component 604 is envisioned, including elongated rounded voids,among others.

As shown in FIGS. 43-45, intubation device 600 may include a pluralityof projections 620 on the surface of intubation device 600, for example,on the surface of the body portion 606 and/or on the surface of the maskportion 607. According to aspects of the invention, projections 620 maybe hollow or non-hollow projections, for example, with or without aninternal void. As shown in FIGS. 43-45, projections 620 may be round orhemispherical in shape, though it is envisioned that aspects of theinvention may include projections 620 that are polygonal in shape, orexample, geodesic in shape, with rounded corners, and provide thedesired function.

Projections 620 may project from the surface of LMA component 604 from0.1 millimeters [mm] to 25 mm, but may typically project from 1 mm to 5mm from the surface of LMA component 604. The dimensions of projections620 may vary depending upon the size and function of projections 620.For example, the width, diameter, or sector length of projections 620may vary from 0.1 mm to 25 mm, but may typically having a widthdimension from 1 mm to 5 mm.

FIG. 46 is a front view of an intubation device 630 having a multipartendotracheal tube (ETT) component 632, a balloon cuff 640, and ballooncuff inflation balloon 642 according to an aspect of the invention.According to this aspect of the invention, the ETT component 632 maycomprise multiple interconnected components, 633, 635, for example, 2 ormore interconnected components, that can be engaged and disengaged asneeded to facilitate assembly, insertion, and/or adjustment of ETTcomponent 632.

Similar to other aspects of the invention disclosed herein, intubationdevice 630 includes an ETT component 632, an LMA component 634 having atube portion 636 and a mask portion 637 having a mask portion opening639, and a conduit (not shown) adapted to engage the ETT component 632,as disclosed herein. Balloon cuff inflation balloon 642 is operativelyconnected, for example, in fluid communication with, inflation cuff 640via one or more tubes, conduits, or passages 644. According to thisaspect of the invention, inflatable balloon cuff 640 positioned on ETTsubcomponent 635 provides a means for manipulating the positioning ofthe distal end of ETT subcomponent 635. For example, in one aspect, atleast partial inflation of inflatable balloon cuff 640 or inflation of aportion of inflatable balloon cuff 640 may assist the anesthesiologistin properly and accurately positioning the distal end of ETTsubcomponent 635 within the patient.

According to this aspect of the invention, the subcomponents 633, 635 ofETT component 632 may be adapted to engage and disengage by anyconventional means, for example, via mechanical fasteners and/orinterference fit, among other means. In the aspect shown in FIG. 46,subcomponents 633 and 635 may engage and/or disengage by threadedconnections, for example, internal threaded connections and/or externalthreaded connections. For example, in the aspect shown in FIG. 46,subcomponent 633 may be larger in size, for instance, larger indiameter, than subcomponent 635 wherein a distal end of subcomponent 633is internally threaded and the proximal end of subcomponent 635 iscorrespondingly externally threaded. The pitch and size of the threadmay vary while providing the desired engagement and/or disengagement ofsubcomponents 633, 635, and any other subcomponents present.

The size of subcomponents 633 and 635 may vary depending upon the sizeand application of aspects of the invention. In one aspect, thediameter, for example, outer diameter of subcomponents 633, 635 mayrange from 1 to 100 mm, but typically, may range from 5 to 15 mm, forexample, about 9-10 mm in diameter.

FIG. 47 is a detailed cross-sectional view of the intubation device 630shown in FIG. 46 as identified by Detail 47 in FIG. 46, according to oneaspect of the invention. In the aspect of the invention shown in FIG.47, ETT subcomponents 633 and 635 are threadably engaged within LMAcomponent 634 in a fashion similar to that shown in FIG. 46. In theaspect of the invention shown in FIG. 47, ETT subcomponent 635 alsoengages coupling 650, for example, a conventional 15 mm connector. As isconventional, coupling 650 can be provided to operatively connect ETTsubcomponent 635 to a source of treatment fluid (not shown), forexample, an oxygen-containing gas.

As also shown FIG. 47, tube or conduit 644 from cuff inflation balloon642 may typically be introduced to intubation device 630 and beoperatively connected to inflation cuff 640 via one or more passages orchannels 646 in LMA component 634. As shown in FIG. 47, passage 646 mayextend within LMA component 634 and exit LMA component 643 to allow tubeor conduit 644 to access inflation cuff 640, for example, by attachingto and/or extending along subcomponent 635 to inflation cuff 640.

FIG. 48 is a front view of an intubation device 660 having a multipartendotracheal tube (ETT) component 662, a balloon cuff 670, and a ballooncuff inflation balloon 672 according to another aspect of the invention.According to this aspect of the invention, the ETT component 662 maycomprise a multiple interconnected components, 663, 665, for example, 2or more interconnected components, that can be engaged and disengaged asneeded to facilitate assembly, insertion, and/or adjustment of ETTcomponent 662.

Similar to other aspects of the invention disclosed herein, intubationdevice 660 includes an ETT component 662, an LMA component 664 having atube portion 666 and a mask portion 667 having a mask portion opening669, and a conduit (not shown) adapted to engage the ETT component 662,as disclosed herein. Balloon cuff inflation balloon 672 is operativelyconnected, for example, in fluid communication with, inflation cuff 670via one or more tubes, conduits, or passages 674. According to thisaspect of the invention, inflatable balloon cuff 670 positioned on ETTsubcomponent 635 provides a means for manipulating the position of thedistal end of ETT subcomponent 665 and/or to at least partially seal acavity into which ETT component 662 is inserted. For example, in oneaspect, at least partial inflation of inflatable balloon cuff 670 orinflation of a portion of inflatable balloon cuff 670 may assist theanesthesiologist in properly and accurately positioning the distal endof ETT subcomponent 665 within the patient.

According to this aspect of the invention, the subcomponents 663, 665 ofETT component 652 may be adapted to engage and disengage in a fashionsimilar to that shown in FIG. 46. However, in the aspect of theinvention shown in FIG. 48, subcomponents 663, 665 engage and/ordisengage via an interlocking mechanism 676.

FIG. 49 is a detailed cross-sectional view of the intubation device 660shown in FIG. 48 showing the engagement of portions of the multipart ETTcomponent 662 via interlocking mechanism 676 as identified by Detail 49shown in FIG. 48.

FIGS. 50 through 58 are views of engineering drawings of one intubationdevice 700 having one or more of the aspects disclosed and describedwith respect to FIGS. 1-49, according to aspects of the invention.

FIG. 50 is a perspective view of intubation device 700 having atranslatable endotracheal tube (ETT) component (not shown) within alaryngeal mask airway (LMA) component 704 according to an aspect of theinvention. FIG. 51 is a perspective view of intubation device 700 shownin FIG. 50 with the LMA component 704 shown in phantom to facilitateillustration of the translatable ETT component 702. FIG. 52 is a sideview of intubation device 700 shown in FIG. 51 with the LMA component704 shown in phantom to facilitate illustration of the translatable ETTcomponent 702. FIG. 53 is a top view of intubation device 700 shown inFIG. 52 with the LMA component 704 shown in phantom to facilitateillustration of the translatable ETT component 702.

Similar to other aspects of the invention disclosed herein, intubationdevice 700 includes a translatable ETT component 702, an LMA component704 having a tube portion 706 and a mask portion 707 having a maskportion opening 709, and a connector 710 adapted to engage the ETTcomponent 702, as disclosed herein. As shown, intubation device 700 alsoincludes a balloon cuff inflation balloon 712 operatively connected, forexample, in fluid communication with, one or more inflation cuffs 713and inflation balloon 712 is adapted to inflate inflation cuff 713 or aportion of inflation cuff 713 via one or more tubes, conduits, orpassages 714. Consistent with the aspects of the invention disclosedherein, the one or more inflatable balloon cuffs 713 are positioned onETT component 702 and provide a means for manipulating the positioningof the distal end of ETT component 702 and/or to at least partially seala cavity into which ETT component 702 is located.

As shown in FIGS. 50 through 53, tube or conduit 714 may engage LMAcomponent 704 via a conduit or sleeve 715, for example, a flexiblesleeve. As also shown in FIGS. 51 through 53, connector 710 adapted toengage the ETT component 702 may include a central conduit or passage720 adapted to communicate with an external source of fluid (not shown),for example, treatment fluid, such as, oxygen-containing gas, and one ormore lateral conduits or passages 722 and 724 adapted to receive sleevetube 714 or other conduits, tubes, and/or instruments introduced tointubation device 700. Further details of connector 710 are providedbelow with respect to FIGS. 54 through 58.

According to one aspect of the invention, conduit or sleeve 715 may beoperatively connected to ETT component 702, for example, attached to ETTcomponent 702, wherein conduit or sleeve 715 may provide a means formanipulating ETT component 702, for example, translating and/or rotatingETT component 702, in a fashion substantially identical to the functionof the manipulation rods or bars disclosed herein. In one aspect, theinsertion and/or extraction of sleeve 715 may axially translate ETTcomponent 702 within LMA component 706; in another aspect, the arcuatemovement of sleeve 715, for example, in an arcuate slot (not shown) inconnector 710, may rotate the ETT component 702 within LMA component706.

FIG. 54 is a perspective view of portions of the connector 710 andrelated components of intubation device 700 shown in FIGS. 50 through 53to illustrate the relationship of these components. As shown in FIG. 54,connector 710 may include a central conduit or passage 720, one or morelateral conduits or passages 722 and 724, and a plate or flange 725.Central conduit 720 may include a first end 727 adapted to communicatewith an external source of fluid (not shown) and a second end 729adapted to receive ETT component 702. As discussed herein, second end729 may include some form of sealing device (not shown) adapted tominimize or prevent leakage between second end 729 and ETT component702.

As also shown in FIG. 54, lateral conduits 724 may be adapted to receiveinflation balloon conduit 714 and/or sleeve 715. FIG. 55 is aperspective view of portions of ETT component 702, inflation balloonconduit 714, and sleeve 715, similar to FIG. 54 but with connector 710removed, to facilitate the illustration of the relationship of thesecomponents. As shown in FIG. 55, sleeve 715 containing conduit 714 maypass through lateral conduit 724 (not whom in FIG. 55) and engage ETTconduit 702 via one or more projections, bars, tabs, brackets, clamps,or plates 731, for example, in a fashion as disclosed herein.

FIG. 56 is a perspective view of portions of the ETT component 702,inflation balloon conduit 714, and sleeve 715, with connector 710removed, similar to FIG. 55, but with sleeve 715 and ETT component 702shown in phantom to facilitate the illustration of aspects of theinvention. As shown most clearly in FIGS. 55 and 56, inflation balloonconduit 714 may pass through sleeve 715 and mount to or be inserted intoETT component 702 and then pass along ETT component 702 to inflatableballoon cuff 713 (see FIGS. 50-53). In one aspect, conduit 714 may passthrough an opening or hole 733 in ETT component 702 prior to extendingto balloon cuff 713.

FIG. 57 is a front perspective view of connector 710 shown in FIG. 54,according to one aspect of the invention. FIG. 58 is a rear perspectiveview of connector 710 shown in FIG. 57. As shown in FIGS. 57 and 58,connector 710 includes a central conduit or passage 720, one or morelateral conduits or passages 722 and 724, and a plate or flange 725.Central conduit 720 includes a first end 727 adapted to communicate withan external source of fluid (not shown) and a second end 729 adapted toreceive ETT component 702. Central conduit 720 may also include anopening or slot 735 sized and positioned to receive tab or plate 731 andconduit 714, as shown in FIG. 54. Lateral conduit 724 may also includean opening or slot 737, opposite opening or slot 737, sized andpositioned to receive tab or plate 731 and conduit 714, as disclosedherein.

As shown in FIG. 58, flange or plate 725 may include one or moreopenings or holes 739 and 741 according to one aspect of the invention.Openings or holes 739 and 741 may be used to introduce conduits, tubes,instruments, and/or structures to connector 710 and intubation device700. For example, as shown in FIG. 54, opening 741 may provide a meansfor introducing conduit 714 and/or sleeve 715 to connector 710, thoughopening 739 may be used in a similar fashion. In addition, openings 739and/or 741 may be used to access intubation device 700 with otherconduits or instruments, for example, for cuff inflation conduits,pressure indicator conduits, image capturing cables, and/or other sensorrelated conduits and/or cables.

The use of any one of the intubation devices disclosed herein may bepracticed with or without the use of a guidance device, that is, adevice used to assist the user in guiding the insertion and placement ofthe intubation devices disclosed herein. According to aspects of theinvention, any conventional guidance device may be used, including athin surgical instrument, or “bougie,” as known in the art, that is, a“hard bougie” or a “soft bougie”; a bronchoscope, for example, a fiberoptic bronchoscope; or any elongated rod, tube, or structure that can beused to assist the user in guiding the insertion and placement of theintubation devices disclosed herein. According to one aspect of theinvention, the guidance device may be placed within the airway of thepatient, and, while in place, any one of the intubation devicesdisclosed herein may be inserted into the airway while threading theguidance device through, for example, the endotracheal tube (ETT)component of an intubation device disclosed herein. Guidance devicesthat may be used when practicing aspects of the invention may include anEschmann-style tracheal tube introducer or bougie provided by variousmanufactures, such as, Teleflex Inc. Insertion of aspects of theinvention into an airway may be facilitated by lubricating theintubation device prior to insertion.

Though many different aspects of the present invention have beenpresented disclosed individually or in combination herein for the sakeof facilitating disclosure, it is envisioned that any one or more of theaspects or features disclosed herein may be combined with any one ormore other aspects of features disclosed herein.

The intubation devices and their subcomponents disclosed herein may befabricated from any conventional material, for example, any conventionalplastic material, elastomeric material, and even wood or metal. In oneaspect, the LMA components and ETT components disclosed herein may befabricated from any one or more the elastomeric materials disclosedherein or any plastic material. For example, the LMA components and ETTcomponents disclosed herein may be fabricated from, for example, apolyamide (PA), for example, nylon; a polyethylene (PE), bothhigh-density polyethylene (HDPE) and low-density polyethylene (LDPE); apolyethylene terephthalate (PET); a polypropylene (PP); a polyester(PE); a polytetrafluoroethylene (PTFE); a polystyrene (PS); anacrylonitrile butadiene styrene (ABS); a polycarbonate (PC); or apolyvinylchloride (PVC); among other plastics.

The intubation devices disclosed herein may also be provided in a broadrange of sizes and dimensions, for example, depending upon the size orage of the patient being treated. Aspects of the invention may beadapted for use with adults, children, infants, and neonates. In oneaspect, embodiments of the invention may be used for veterinarytreatment, for example, with animals. For example, the intubationdevices may have an overall length ranging from about 3 inches to about2 feet, but may typically range in length from about 6 inches to about12 inches, for example, about 10 inches in length. Similarly, theintubation devices disclosed herein may have an overall width rangingfrom about 1 inch to about 1 foot, but may typically range in width fromabout 2 inches to about 3 inches, for example, about 2½ inches in width.

In support of the development and optimization of the present invention,the effectiveness and ease of use of aspects of the invention wereevaluated using medical training mannequins. Specifically, the ease ofuse and effectiveness of aspects of the present invention wereinvestigated and evaluated using a Laerdal airway management trainingmannequin (model no. 25000033) and a TruCorp intubation-trainingmannequin (model AirSim Combo Bronchi X 1021550).

Aspects of the invention were evaluated with and without the use ofguidance devices, that is, with and without the uses of a “bougie,” asdisclosed herein. In one set of evaluations a bronchoscope, for example,a fiber optic bronchoscope, was used as a guidance device.

The specific testing investigated whether aspects of the invention couldeffectively be inserted and positioned within the airway of the patientand whether the ETT component could be advanced in the airway using themanipulation rods mounted to the ETT component as disclosed herein. Thepositioning of aspects of the invention was evaluating using afiber-optic bronchoscope inserted into the intubation device.

The testing revealed that aspects of the present invention could beeffectively inserted and positioned within the airways of the mannequinswith and without guidance devices, for example, with or without a bougieor with a bronchoscope. In addition, once placed in the airway of themannequins the ETT component could be effectively advanced, for example,into the trachea, using the manipulation rods disclosed herein. Also,this testing revealed that the insertion of the ETT component into theairway may be improved by 1) removing the bevel on the distal end of theETT component tube and/or 2) selectively locating the direction of thebevel, for example, to direct the face of the bevel toward the anteriordirection. Based upon the insights and success of this preliminarytesting, further testing and evaluation are planned.

Accordingly, in one aspect of the invention, any one of the distal endsof the ETT component tubes disclosed herein may be substantiallynon-beveled, for example, having an exposed cross-section substantiallyperpendicular to the axis of the tube.

In another aspect, any one of the distal ends of the ETT component tubesdisclosed herein may have a bevel, directed in a predetermineddirection, for example, having a bevel directed in an anterior directionof the patient. The bevel may have a bevel angle ranging from 30 degreesto 60 degrees, for example, a 45 degree bevel.

Though various aspects and embodiments of the invention are disclosedherein that can be used or adapted for intubation during surgery, it isenvisioned that aspects of the invention may be adapted for anyapplication where patient or victim intubation is advantageous, thatincludes in the emergency room (ER), in the operating room (OR), or byfirst responders, paramedics, and emergency medical technicians (EMTs)at accidents or other calamities. It is envisioned that aspects of theinvention may be particularly advantageous for neurosurgery and/or brainsurgery where the prevention of coughing, which may undesirably induceintra-cranial pressure (ICP) during extubation, is desired. Otherapplications of aspects of the invention are bronchoscopy thoracicsurgery, obstetrics, cardiac catheterization, laparoscopic procedures,and plastic surgery, among other medical procedures, and training, forexample, training of anesthesiologists.

As disclosed herein, aspects of the invention include intubation devicesand their method of use that address many of the disadvantages of priorart devices and methods.

While various embodiments have been described above, it should beunderstood that these embodiments and their many aspects have beenpresented by way of example, and not limitation. It will be apparent topersons skilled in the relevant art that various changes in form anddetail can be made therein without departing from the spirit and scopeof the invention. Moreover, it is to be understood that the variousembodiments of the invention, although different, are not necessarilymutually exclusive. Furthermore, a particular feature, structure, orcharacteristic described herein in connection with one embodiment may beimplemented within other embodiments without departing from the scope ofthe invention. In addition, it is to be understood that the location orarrangement of individual elements within each disclosed embodiment maybe modified without departing from the scope of the invention. Thedetailed description presented herein, therefore, is not to be taken ina limiting sense, and the scope of the present invention is defined onlyby the appended claims, appropriately interpreted, along with the fullrange of equivalents to which the claims are entitled.

Although the term “at least one” may often be used in the specification,claims and drawings, the terms “a”, “an”, “the”, “said”, etc. alsosignify “at least one” or “the at least one” in the specification,claims and drawings.

While several aspects of the present invention have been described anddepicted herein, alternative aspects may be affected by those skilled inthe art to accomplish the same objectives. Accordingly, it is intendedby the appended claims to cover all such alternative aspects as fallwithin the true spirit and scope of the invention.

1-58. (canceled)
 59. An intubation device connector mountable to alaryngeal mask airway (LMA), the connector comprising: A central conduithaving a first end adapted to communicate with an external source offluid and a second end adapted to receive an endotracheal tubepositioned in the LMA; and one or more lateral conduits mounted to thecentral conduit; wherein at least one of the one or more lateralconduits is adapted to receive an elongated member operatively connectedto the endotracheal tube.
 61. The connector as recited in claim 59,wherein the elongated member comprises one of a tube, a conduit, and asleeve.
 62. The connector as recited in claim 59, wherein the elongatedmember operatively connected to the endotracheal tube is movable andadapted to manipulate the endotracheal tube.
 63. The connector asrecited in claim 62, wherein the elongated member operatively connectedto the endotracheal tube is adapted to at least one of translate androtate the endotracheal tube.
 64. The connector as recited in claim 59,wherein the connector further comprises a plate to which the centralconduit and the one or more lateral conduits are mounted.
 65. Theconnector as recited in claim 64, wherein in the plate comprises aflange.
 66. The connector as recited in claim 59, wherein the second endof the central conduit comprises a sealing device adapted to minimizeleakage between the second end the central conduit and the endotrachealtube.
 67. The connector as recited in claim 66, wherein the sealingdevice comprises an elastomeric sealing device.
 68. The connector asrecited in claim 59, wherein the elongated member comprises a moveablesleeve operatively connected to the endotracheal tube.
 69. The connectoras recited in claim 68, wherein the connector further comprises aconduit positioned within the movable sleeve.
 70. The connector asrecited in claim 69, wherein the conduit positioned within the movablesleeve comprises an inflation balloon conduit having a first endoperatively connected to a source of inflation fluid and a second end,opposite the first end, operatively connected to an inflation balloon.71. The connector as recited in claim 70, wherein the inflation balloonis mounted to the endotracheal tube.
 72. The connector as recited inclaim 62, wherein the elongated member is operatively connected to theendotracheal tube by one of a projection, a bar, a tab, a bracket, aclamp, and a plate.
 73. The connector as recited in claim 59, whereinthe elongated member is operatively connected to the endotracheal tubeby a projection, and wherein the second end of the central conduitcomprises an opening adapted to receive the protection.
 74. Theconnector as recited in claim 73, wherein the at least one of the onemore lateral conduits adapted to receive the elongated member comprisesan opening adapted to receive the projection of the elongated member.75. The connector as recited in claim 68, wherein the movable sleevecomprises a flexible movable sleeve.
 76. The connector as recited inclaim 59, wherein the fluid comprises a treatment fluid.
 77. Theconnector as recited in claim 76, wherein the treatment fluid comprisesan oxygen-containing gas.
 78. The connector as recited in claim 59,wherein the endotracheal tube comprises a translatable endotrachealtube.